Product Recall

Definition

Product recall is a process taken by the manufacturer, importer and wholesaler to remove or withdraw a particular products from all links of distribution.

The removal or withdrawal may be due to critical quality defects discovered or serious adverse drug reactions reported which might cause health risks to users of the products.

Decision For Recall

The decision for recall shall be made when there is or may caused potential risk to the user of the products by reason of faulty production or on medical grounds:

a) Voluntarily undertaken by the manufacturers and distributors.

b) As directed by the Director of Pharmaceutical Services, Ministry of Health.

Unless the Director of Pharmaceutical Services, Ministry of Health has already specified the degree and level of a particular products recall, the degree and level will be decided by the company’s Product Recall Committee based on risks involved. The Product Recall Committee shall comprise of personnel who are responsible for the execution and coordination of recall. The persons responsible shall handle all aspects of the recalls with the appropriate degree of urgency.

No recall shall take place without first consulting/informing the Authority.

Recalls that involve specific batch will not involve any other batch/batches that currently available in the market.

Not all recalls are initiated because a product is deemed unsafe or ineffective. A recall may also be conducted to remove products from the Malaysian market with quality defects that do not affect their safety and efficacy.

Degree of Recall

The degree of recall is classified according to the severity of quality defects and adverse reactions of the products.

Degree	Definition	Recall Notice by PRH
I	Products with major health risks that might cause serious injuries or death. Should be under an embargo within 24 hours	Within 24 hours of recall commencement or directive
II	Products with minor health risks or are substandard. Should be under an embargo within 72 hours	Within 48 hours of recall commencement or directive
III	Products with other reasons for recall that can cause health risks to users. Should be under an embargo within 30 days or as specified	Within 72 hours of recall commencement or directive

Level of Recall

The level of recall depends on the nature of problem, extent of the product’s distribution and degree of hazard involved.

Level A: To all consumers (end users).

Level B: To all points of sales (e.g. Hospitals, Pharmacies, Clinics, Specialist Centres).

Level C: To all sub-distributors (wholesalers).

Public Notification

Not all recalls are announced in press releases. However, when a product that has been widely distributed or poses a serious health hazard is recalled, NPRA may do so if the agency determines it is necessary to protect consumers.

References:

1) Drug Registration Guidance Document (DRGD)

2) Guideline on Good Distribution Practice

Products as listed below have been recalled from the market.

Year 2026

No	Product Name	Registration Number	Active ingredients	Batch Number	Reason for Recall	Degree and Level of Recall	Registration Holder	Date of recall
1	Coredin Paediatric Linctus	MAL19880311AZ	Ammonium Chloride Diphenhydramine Hydrochloride	19574, 19616	Precautionary measure following a complaint regarding the presence of particles confirmed to have originated from sugar crystallization in the product formulation.	Voluntary recall at the point of sub-distributor (wholesaler)	TERAPUTICS SDN BHD	30 January 2026
2	Vamlo Tablets 10mg	MAL07010993AZ	Amlodipine	24030132	Out of Trend (OOT) result for Related Substances “Impurity D” test at 18th month timepoint of stability study.	Voluntary recall up to the point of sales	RANBAXY (MALAYSIA) SDN. BHD.	13 February 2026
3	Doxycillin Tablet 100mg	MAL19860580AZ	Doxycycline Hydrochloride/ Hyclate	2403300, 2403301, 2405293	Out of specification result for related substance “Impurity C” test during the stability study.	Voluntary recall up to the point of sales	DUOPHARMA MANUFACTURING (BANGI) SDN. BHD.	19 February 2026
4	Uphamol Menstrual Tablet 500/25mg	MAL12025061X	Paracetamol Pamabrom	2310222	Out-of-specification result was observed for the dissolution test during the stability study.	Voluntary recall up to the point of sales	Duopharma Marketing Sdn. Bhd.	9 February 2026
5	Gastrografin Aqueous Solution	MAL20001254ACRZ	Amidotrizoic acid Meglumine	MA04LDV M1, MA04LDV M2, MA04MPS M1, MA04MPS M2	Precautionary measure following the detection of trace amounts of nitrosamine N-nitroso-meglumine above the acceptable intake limit in seven tested batches of the formulation without star anise oil.	Voluntary recall up to the point of sales	Bayer Co. (Malaysia) Sdn. Bhd.	9 Mac 2026
6	Pro-Stisol Waist & Body Tonic Tablet	MAL16100054T	Cornus officinalis Dioscorea opposita Radix Rehmanniae Glutinosa	013/2412 T22-004	The batch tested by NPRA had failed physical appearance test	Degree III recall up to the point of sales	Pro Stisol Manufacturing	13 Mac 2026
7	Vitamode Astaxanthin Plus Glutathione Capsule	MAL15045003NC	L-glutathione Haematococcus Pluvialis Extract	5NC10503	Product labelling on the blister strip found to be incorrect.	Voluntary recall up to the point of sales	Medispec (M) Sdn. Bhd.	16 Mac 2026
8	Axcel Mometasone 0.05%w/w Nasal Spray	MAL14025010AZ	Mometasone Furoate	B2509050, B2509050A, B2509064A	Out of Specification (OOS) for microbial limit test was detected during the stability study programme.	Voluntary recall up to all consumers level (end users)	Kotra Pharma (M) Sdn. Bhd.	10 April 2026
9	Glumet XR Tablet 500mg	MAL13015050AZ	Metformin Hydrochloride 500mg	5036723	Detection of N-Nitrosodimethylamine (NDMA) above acceptable levels.	Degree II recall up to the point of sales	Pharmaniaga Manufacturing Berhad	15 April 2026
10	Glumet XR Tablet 750mg	MAL13025046AZ	Metformin Hydrochloride 750mg	5031724	Detection of N-Nitrosodimethylamine (NDMA) above acceptable levels.	Degree II recall up to the point of sales	Pharmaniaga Manufacturing Berhad	15 April 2026
11	Glumet XR Tablet 500mg	MAL13015050AZ	Metformin Hydrochloride 500mg	5028486 5032332 5032334 2034104 5034103 5034100 5036722 5036724 5036723 5037167 5036983 5036984 5038424 5039549 5040444	Detection of N-Nitrosodimethylamine (NDMA) above acceptable levels.	Voluntary recall up to the point of sales	Pharmaniaga Manufacturing Berhad	14 May 2026
12	Glumet XR Tablet 750mg	MAL13025046AZ	Metformin Hydrochloride 750mg	5029183 5030138 5030777 5030778 5030779 5031726 5031728 5031724 5032581 5032577 5033837 5034636 5035512 5035844 5037253 5040469	Detection of N-Nitrosodimethylamine (NDMA) above acceptable levels.	Voluntary recall up to the point of sales	Pharmaniaga Manufacturing Berhad	14 May 2026
13	Apalin 250mg Injection (2ml Amp)	MAL19984033AZ	Amikacin Sulphate	242837T	The batch tested by NPRA had failed sterility test	Degree I recall up to the point of sales	Duopharma (M) Sdn. Bhd	14 May 2026
14	Vegesamine Capsule 500mg	MAL08111949XR	Glucosamine HCl	1770600A (182/AO), 1770600A (182/AO), 1770600A (182/AO), 1770600A (182/AP), 1770600A (182/AP), 1770600A (182/AP), 698300 (182/AQ), 698300 (182/AQ)	This recall is being conducted because the product registration has expired on 7th December 2025 and exemption period for marketing purpose is coming to an end on 6th June 2026.	Voluntary recall up to the point of sales	21st Century Products Sdn. Bhd.	20 May 2026
15	Nature's Green Ying Nin Tablets	MAL14105008T	Multiple active ingredients	2505311	The batch tested by NPRA had failed physical appearance test.	Degree III recall up to the point of sales	Tong Jum Chew (M) Sdn. Bhd.	15 June 2026
16	NutrinLife Man Pro Capsule	MAL19036043NCR	Serenoa Repens Berry Extract (Saw Palmetto) Zinc Oxide	H09823310	Out of Specification result was observed for zinc content (ICP-OES).	Voluntary recall up to the point of sales	Biofunction Marketing Sdn. Bhd	19 June 2026
17	Doxycillin Tablet 100mg	MAL19860580AZ	Doxycycline Hydrochloride	2410251, 2410252, 2410253, 2410254 2503230, 2503231, 2503232	Out of Specification (OOS) for Related Substances (Impurity F test) was detected during batch monitoring following a previous product recall exercise.	Voluntary recall up to the point of sales	Duopharma Manufacturing (Bangi) Sdn. Bhd.	25 June 2026
18	Decondine Syrup	MAL19860261AZ	Triprolidine Hydrochloride Pseudoephedrine Hydrochloride	307-24002, 307-24003, 307-24004, 307-24005, 307-24008, 307-24009, 307-24010, 307-24011, 307-24012, 307-24013	Precautionary measure following the out-of-specification result was observed for the assay test (Triprolidine HCL) for batch 307-22007 at the 30-month stability study time point, which is near the end of the product’s shelf life.	Voluntary recall at the point of sub-distributor (wholesaler)	Sunward Pharmaceutical Sdn. Bhd.	3 July 2026
19	Idaman Pharma Enalapril Tablet 5mg	MAL23116014AZ	Enalapril Maleate	5034698	Out of Specification result was observed for dissolution test at 18 month timepoint stability testing.	Voluntary recall up to the point of sales	Inspirapharma Sdn. Bhd.	8 July 2026
20	Lanzotred soft capsules (Enzalutamide Soft capsules 40 mg)	MAL22096035AZ	Enzalutamide	F10753P2 & G19850P2	Out of Specification result was observed for the impurity Enzalutamide Dioxoimidazolidine.	Voluntary recall up to the point of sales	Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.	3 August 2026
21	TSART 40 (Telmisartan Tablets USP 40mg)	MAL19056110AZ	Telmisartan	25142819	Out of Specification result was observed for the product description at 9th months stability time point.	Voluntary recall at the point of sub-distributor (wholesaler)	Ascend Laboratories Sdn. Bhd.	4 August 2026
Last updated 07/08/2026

Year 2025

No	Product Name	Registration Number	Active ingredients	Batch Number	Reason for Recall	Degree and Level of Recall	Registration Holder	Date of recall
1	Bio Spektra Inji Plus Capsule	MAL11125063TC	Multiple active ingredients	MAI23039	The batch tested by NPRA found to contain Total Aerobic Microbial Count and Total Yeasts and Moulds Count above allowable limit	Degree III recall up to the point of sales	AK Pharmacy & Naturopathy Center	7 January 2025
2	Hongjitang Xin Angong Niuhang Pill	MAL20172976T	Multiple active ingredients	2402001	The batch tested by NPRA found to contain arsenic and mercury above allowable limit	Degree II recall up to the point of sales	Hai-O Medicine Sdn. Bhd.	7 January 2025
3	Ban Kah Chai Gold Brand Fu Leu Wu Chin Wan	MAL20020656T	Multiple active ingredients	2401-24A07	The batch tested by NPRA found to contain cadmium above allowable limit	Degree II recall up to the point of sales	Ban Kah Chai Pharmaceutical Sdn. Bhd.	7 January 2025
4	Ban Kah Chai Herbal Capsule	MAL20020653T	Multiple active ingredients	2404-24D05	The batch tested by NPRA found to contain cadmium above allowable limit	Degree II recall up to the point of sales	Ban Kah Chai Pharmaceutical Sdn. Bhd.	7 January 2025
5	Zaipermai Capsule Faruqi	MAL22096119TC	Multiple active ingredients	TA3ZZA3ZZSF 003-24	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall up to the point of sales	Zai Permai Resources	7 January 2025
6	Ubat Serbuk Sakit Perut Cap Tangan	MAL19984513T	Multiple active ingredients	S2310001	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall up to the point of sales	Ban An Tsi Company Sdn. Bhd.	7 January 2025
7	Yi Shi Yuan Red Yeast Rice 300mg Capsule	MAL17126023T	Monascus purpureus	B11001	The batch tested by NPRA found to contain Lovastatin above the allowable limit.	Degree III recall up to the point of sales	Yi Si Yuan Trading Sdn. Bhd.	7 January 2025
8	RO-CAL 0.25mcg	MAL10070596X	Calcitriol	1) 23G24 2) 23G25 3) 23G26	Out-of-specification result for the product’s description and assay test during stability study	Voluntary recall up to the point of sales	Pahang Pharmacy Sdn. Bhd.	24 January 2025
9	NW Methyl Salicylate 25%W/W Ointment	MAL18046134X	Methyl salicylate	1) NW25M27016 2) NW25M27017 3) NW25M27018 4) NW25M27019 5) NW25M27024 6) NW25M27025 7) NW25M27026	Batches of product manufactured and distributed without valid manufacturing license due to GMP issue	Degree II recall up to the point of sales	Natural Wellness Industries Sdn. Bhd. (Milik Penuh Nutrivention Sdn. Bhd)	14 February 2025
10	Natural Wellness Aqueous Cream	MAL20172844X	White soft paraffin Emulsifying Wax Liquid Paraffin	1) NW25M27035 2) NW25M27036 3) NW25M27037 4) NW25M27038 5) NW25M27039 6) NW25M27040 7) NW25M27041 8) NW25M27042 9) NW25M27001 10) NW25M27002 11) NW25M27003 12) NW25M27004 13) NW25M27005 14) NW25M27006 15) NW25M27007 16) NW25M27008 17) NW25M27009 18) NW25M27010 19) NW25M27011 20) NW25M27012 21) NW25M27013 22) NW25M27014 23) NW25M27015 24) NW25M27027 25) NW25M27028 26) NW25M27029 27) NW25M27030 28) NW25M27031 29) NW25M27032 30) NW25M27033 31) NW25M27034	Batches of product manufactured and distributed without valid manufacturing license due to GMP issue	Degree II recall up to the point of sales	Natural Wellness Industries Sdn. Bhd. (Milik Penuh Nutrivention Sdn. Bhd)	14 February 2025
11	Petani Kapsul Pukul Angin	MAL06111395T	Multiple active ingredients	A352KPA	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit.	Degree III recall up to the point of sales	Syarikat Zulkifli Bamadhaj (Malaysia)	28 February 2025
12	Listra Habbasauda Plus Capsules	MAL17106012TC	Nigella sativa Trigonella foenum-graecum	TAAAZZAALA01124	The batch tested by NPRA was found to contain Total Aerobic Microbial Count and Bile-tolerant Gram-Negative Bacteria above the allowable limit.	Degree III recall up to the point of sales	Bina Mutiara Global Sdn. Bhd.	28 February 2025
13	Shangshi Koyok	MAL14125040TC	Panax notoginseng Capsicum frutescens	38320701	The batch tested by NPRA was found to contain unapproved Methyl Salicylate and Menthol.	Degree II recall up to the point of sales	Teong Huat Medical Sdn. Bhd.	28 February 2025
14	Herbal Farm N7 Capsule	MAL22046118TC	Multiple active ingredients	NSC24067	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall up to the point of sales	Herbal Farm	28 February 2025
15	Dexin Injection 2mL	MAL20013450AZ	Dexamethasone	DX 24A 001	The batch tested by NPRA had failed assay test for Propyl Paraben and Methyl Paraben	Degree III recall up to the point of sales	Sm Pharmaceuticals Sdn. Bhd.	28 February 2025
16	Famodine Tablet 20mg	MAL19096018AE	Famotidine	231015	Batch showed out-of-specification (OOS) of Famotidine assay result during stability studies.	Voluntary recall up to the point of sales	Duopharma (M) Sendirian Berhad, Malaysia	25 March 2025
17	Neupogen 30MIO 0.3mg/ml Vial	MAL19921256AZ	Recombinant Human Granulocyte Colony-stimulating Factor (Filgrastim)	1155389 1159120 1161429 1163920 1164773 1168146 1168467 1170219 1177267 1179510 1182100	Out of specification (OOS) for purity test was observed in Inspected Drug Product (IDP) failed purity testing at 36 months stability study, showing less than 95% purity.	Voluntary recall up to the point of sales	Amgen Biopharmaceuticals Malaysia Sdn. Bhd.	26 March 2025
18	SHH Habib Roll On Gel	MAL22026104TC	Multiple active ingredients	TAAAZA 112-23	The batch tested by NPRA was found to contain undeclared Methyl Salicylate.	Degree III recall up to the point of sales	SHH Northern Legacy (M) Sdn. Bhd.	21 April 2025
19	Nutriflex Omega Special Emulsion For Infusion	MAL14115005AZ	Multiple active ingredients	240678051	This recall is being conducted due to an out-of-specification result for the product’s physical appearance test during stability study	Voluntary recall up to the point of sales	B.Braun Medical Industries Sdn. Bhd.	30 April 2025
20	Teleact Tablets 80mg	MAL13015032AZ	Telmisartan	MLG0026A	OOS (out-of-specification) & OOT (out-of-trend) for Microbial Limit Test in the API batches used in the manufacturing batch	Voluntary recall up to the point of sales	Ranbaxy (Malaysia) Sdn. Bhd.	30 April 2025
21	Utrogestan 100mg Capsule	MAL19971796ACZ	Progesterone	252130	This recall is being conducted due to labelling error on the outer packaging.	Voluntary recall up to the point of sales	Syarikat WellChem Sdn. Bhd.	30 April 2025
22	ELONIDE Nasal Spray 50 mcg/dose	MAL12015004AZ	Mometasone Furoate	1) 06387206 2) 06367206 3) 06357206 4) 06377206 5) 07157206 6) 07167206 7) 1223C206 8) 1224C206 9) 1225C206 10) 1283C206 11) 1320C206 12) 1321C206 13) 00711304 14) 00721306 15) 01102306 16) 01112306 17) 01122306 18) 01132306 19) 01293206 20) 01302306 21) 1051A306 22) 1052A306 23) 1142B306 24) 1143B306 25) 1589C406 26) 1590C406 27) 1591C406 28) 05866206 29) 1222C206 30) 02483306	This recall is being conducted due to the detection of bacterial contamination in several batches.	Voluntary recall up to all consumers level (end users)	Hoe Pharmaceuticals Sdn. Bhd.	8 May 2025
23	Depropin Tablet 25mg	MAL20012730AZ	Dothiepin HCl	230985L	Batch showed out-of-specification (OOS) of Dothiepin Hydrochloride assay result during Zon IVB real-time stability studies.	Voluntary recall up to the point of sales	Duopharma (M) Sendirian Berhad, Malaysia	16 May 2025
24	Vigouroxy	MAL06091569T	Multiple active ingredients	062409V	Batch showed cadmium assay is above the allowable limit.	Voluntary recall up to the point of sales	Nature's Grace (M) Sdn. Bhd.	29 May 2025
25	PROMUNE mbg Capsule	MAL18126019NC	Beta Glucan	N2411P	The batch tested by NPRA was found to contain Bile-Tolerant Gram-Negative Bacteria above the allowable limit.	Degree II recall up to the point of sales	Powerlife (M) Sdn. Bhd.	26 June 2025
26	Chang-Sze-Long Badu Gao	MAL13095093T	Multiple active ingredients	All batches	The batch tested by NPRA was found to contain mercury above the allowable limit.	Degree II recall up to the point of sales	Nang Hin Medical Sdn. Bhd.	26 June 2025
27	Jinfeng Powder	MAL20032104T	Multiple active ingredients	J230618	The batch tested by NPRA was found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall up to the point of sales	Di Ann Trading	26 June 2025
28	Herbal Farm Reposin Capsule	MAL13055039TC	Multiple active ingredients	RPN24028	The batch tested by NPRA was found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall up to the point of sales	Herbal Farm	26 June 2025
29	Minosis Leemi Powder	MAL17117003TC	Multiple active ingredients	24M2042	Batch showed out-of-specification (OOS) on Total Aerobic Microbial Count (TAMC) and Total Yeast and Moulds Count (TYMC).	Voluntary recall up to the point of sales	Leong 23 Sdn. Bhd.	27 June 2025
30	Teleact Tablets 80mg	MAL13015032AZ	Telmisartan	MLF0133A MLG0175A	OOS (out-of-specification) & OOT (out-of-trend) for Microbial Limit Test in the API batches used in the manufacturing batch.	Voluntary recall up to the point of sales	Ranbaxy (Malaysia) Sdn. Bhd.	14 July 2025
31	Betanor 24mg Tablet	MAL14075064AZ	Betahistine Dihydrochloride	2410108 2410109 2411059 2501072 2501073 2502085 2502086 2505031	Batch showed out-of-specification (OOS) of N-nitroso-betahistine impurity.	Voluntary recall up to the point of sales	Noripharma Sdn. Bhd.	22 July 2025
32	Minyak Angin Orang Satu Mata	MAL05121191X	Camphor Eucalyptus Oil Menthol Crystal Methyl Salicylate	BBL908	The batch tested by NPRA had failed Methyl Salicylate and Camphor assay tests.	Degree III recall up to the point of sales	Wen Jiang Medical Industries Sdn. Bhd.	22 July 2025
33	Cap Gunting Chai Teck Sang Shui Gan Teh 12gm	MAL20116092TC	Multiple active ingredients	24F043	The batch tested by NPRA was found to contain Total Aerobic Microbial Count and Bile-tolerant Gram-Negative Bacteria above the allowable limit.	Degree III recall up to the point of sales	Chai Teck Sang Medical Hall Sdn. Bhd.	22 July 2025
34	Calcium Carbonate Tablets ‘MPI’ 500mg	MAL19940309X	Calcium Carbonate	All batches	Data Integrity Issues In Relation To Quality Control Tests (Dissolution)	Degree II recall at the point of sub-distributor (wholesaler)	Malaysian Pharmaceutical Industries Sdn. Bhd.	4 August 2025
35	STOPCOF Oral Liquid	MAL09062117T	Multiple active ingredients	S24001, S24002, S24003, S24004	Batches showed an unusual “pop” sound and gas release upon opening the bottle.	Voluntary recall up to the point of sales	Jetpharma Sdn. Bhd.	8 August 2025
36	Fucidin Tablet 250mg (Film Coated)	MAL19910821AZ	Sodium Fusidate	C97089	Batch showed out-of-specification (OOS) of impurities during the stability study.	Voluntary recall up to the point of sales	DKSH Malaysia Sdn. Bhd.	8 August 2025
37	NW Chlorhexidine Gluconate 5%W/V Topical Solution	MAL18046124XZ	Chlorhexidine Gluconate	NW24M26423 NW24M26454	The batch tested by NPRA had failed Chlorhexidine Gluconate Content – HPLC test.	Degree II recall up to the point of sales	Natural Wellness Industries Sdn. Bhd.	20 August 2025
38	ZBT Wenxin Granule	MAL09072822T	Multiple active ingredients	2501023	Product labelling found to be not compliant with current labelling requirements.	Degree III recall up to the point of sales	ZBT Far East Sdn. Bhd.	20 August 2025
39	Xie Fu Zhu Yu Tang Extract Granules C.F.T	MAL13115096T	Multiple active ingredients	K0582401M	The batch tested by NPRA found to contain Bile-Tolerant Gram Negative Bacteria above allowable limit	Degree III recall up to the point of sales	Chuan Feng Tang Pharmaceutical (M) Sdn. Bhd.	20 August 2025
40	Tranpam Tablet 1mg	MAL19900510A	Lorazepam	All batches	Data Integrity Issues In Relation To Quality Control Tests (Related Substances; Total Impurities)	Degree II recall up to the point of sales	Malaysian Pharmaceutical Industries Sdn. Bhd.	21 August 2025
41	Soft Flow SC Low Calcium (2.5MEQ/L) Peritoneal Dialysis Solution With Dextrose 2.5% W/V	MAL18116040AZ	Multiple active ingredients	P4J034-1A12 P4J034-1A13 P4J035-1A11 P4J035-1A12 P4J035-1A13 P4J036-1A11 P4J037-1A11 P4J037-1A12 P4J038-1A11 P4J038-1A12 P4J039-1A11 P4J039-1A12 P4J039-1A13 P4J040-1A11 P4J040-1A12 P4J041-1A11 P4J041-1A12 P4J041-1A13 P4J042-1A11 P4J042-1A12 P4J043-1A11 P4J043-1A12 P4J043-1A13 P4J044-1A11 P4J044-1A12 P4J044-1A13 P4J045-1A11 P4J045-1A12 P4J046-1A11 P4J046-1A12 P4J047-1A11 P4J047-1A12 P4J047-1A13 P4K001-1A11 P4K001-1A12 P4K002-1A11 P4K002-1A12 P4K002-1A13 P4K003-1A11 P4K003-1A12 P4K004-1A11 P4K004-1A12 P4K004-1A13 P4K005-1A11 P4K005-1A12	The voluntary recall is planned following complaints received from users related to leakage of dialysate out into the sealed outer pouch, which may potentially pose a risk to patients, if outer pouch is breached and undetected prior to use.	Voluntary recall up to the level of hospital and consumers	Peritone Health Sdn. Bhd.	25 August 2025
42	Pharmaniaga Co-Amoxiclav Tablet 625mg	MAL20013767AZ	Amoxycillin Trihydrate & Clavulanic Acid	5031276	Out-of-specification result for the product’s description during stability study.	Voluntary recall up to the point of sales	Idaman Pharma Manufacturing Sdn. Bhd.	18 August 2025
43	Nisol Injection (10ml Vial)	MAL20041207AZ	Nisol Injection (10ml Vial)	250965L	Recall due to mislabeling issue reported by a customer.	Voluntary recall up to the point of sales	Duopharma (M) Sendirian Berhad	7 Oktober 2025
44	Hyomide Tablet 10mg	MAL05101675AZ	Hyoscine Butylbromide	2311021 and 2311022	Recall due to shortened shelf life approved by NPRA from 3 years to 2 years.	Voluntary recall up to the point of sales	Duopharma Maufacturing (Bangi) Sdn Bhd	9 Oktober 2025
45	Natural Wellness Calamine Cream	MAL11120009XZ	Calamine & Zinc Oxide	NW24M26868 and NW24M26869	The batch tested by NRA had failed zinc content – residue on ignition	Degree II recall up to the point of sales	Natural Wellness Industries Sdn. Bhd. (Milik Penuh Nutrivention Sdn. Bhd)	30 Oktober 2025
46	21st Century Herbal Lipo Tea Natural Flavor	MAL20012794TR	Panax Ginseng Cassia Augustifolial Althaea Officinalis/ Marshmallow Root	All batches	The Cassia content in these products exceeds the current allowable limit under the latest Drug Registration Guidance Document (DRGD).	Voluntary recall up to the point of sales	21st Century Products Sdn. Bhd.	31 Oktober 2025
47	21st Century Herbal Lipo Tea Honey Lemon Flavor	MAL20012801TR	Panax Ginseng Cassia Augustifolial Althaea Officinalis/ Marshmallow Root	All batches	The Cassia content in these products exceeds the current allowable limit under the latest Drug Registration Guidance Document (DRGD).	Voluntary recall up to the point of sales	21st Century Products Sdn. Bhd.	31 Oktober 2025
48	MIVACRON 2MG/ML INJ. 10ML AMPOULE	MAL19940410AZ	Mivacurium Chloride	XP1TJ	Deficiencies in manual visual inspection (MVI) were detected between December 2024 and September 2025. According to the investigation, potentially not all glass particles in the ampoules have been detected during the MVI process.	Voluntary recall up to the point of sales	Aspen Medical Products Malaysia Sdn Bhd	7 November 2025
49	Hurix's Cream For Mouth Ulcer Plus (With Aloe Vera)	MAL21086097TC	Multiple active ingredients	M004 250601, M004 250701	A complaint was received regarding a quality issue involving a colour change, whereby the product colour was found to be inconsistent with the specified product specification.	Voluntary recall up to the point of sales	JIN BIN CORPORATION SDN. BHD.	25 November 2025
50	Clarem 250 Tablet	MAL20040981AZ	Clarithromycin	113107, 108385	CEP for API manufacturer, SM Biomed Sdn. Bhd. was withdrawn by EDQM following non-compliance with GMP during inspection by Belgium authority on the 6th-8th October 2025.	Voluntary recall up to the point of sales	Eucogen Sdn. Bhd.	28 November 2025
51	HEPARINOL 5000 IU/ML	MAL19870139AZ	Heparin Sodium	L22H0035	Failed potency limit test (specification: 90-110%)	Degree I recall up to the point of sales	AIN MEDICARE SDN. BHD.	19 December 2025
52	Panadol Menstrual Caplet	MAL19961356XR	Paracetamol Pamabrom	All batches manufactured from February 2024 until December 2025	Out-of-specification result was observed for the dissolution parameter for batch XV8R at the 18-month stability study timepoint. As a precautionary measure, the company extends the recall to all batches manufactured from February 2024 until December 2025.	Voluntary recall up to the point of sales	Haleon Malaysia Sdn. Bhd.	22 December 2025
Last updated 23/04/2026

Year 2024

No	Product Name	Registration Number	Active ingredients	Batch Number	Reason for Recall	Degree and Level of Recall	Registration Holder	Date of recall
1	Axcel Cimetidine-200 Suspension	MAL19940272AZ	Cimetidine 200mg/5ml	B2305045	The assay of cimetidine and preservative sodium benzoate conducted on batch B2305045 with pack size 100mL was found to be out of specifications during real time stability study at 3 and 6 months point.	Voluntary recall up to the point of sales	Kotra Pharma (M) SB	23 January 2024
2	Tenormin Tablet 50mg	MAL19870055ACZ	Atenolol 50mg	6004731	label incompliance	Voluntary recall up to the point of sales	DKSH Malaysia Sdn Bhd	01 February 2024
3	Herbanika Barut	MAL20014435T	Herbs	2211351	The batch tested by NPRA found to contain Total Aerobic Microbial Count and Total Yeasts and Moulds Count above allowable limit	Degree III recall up to the point of sales	MISB Resources Sdn Bhd, Malaysia	01 February 2024
4	Ubijaga Tongkat Ali Plus	MAL06021354T	Herbs	T354UT30	The batch tested by NPRA found to contain Total Aerobic Microbial Count and Bile-Tolerant Gram Negative Bacteria above allowable limit	Degree III recall up to the point of sales	Syarikat Zulkifli Bamadhaj, Malaysia	01 February 2024
5	Kapsul Habbatus Sauda 300mg	MAL06051554T	Semen Nigella sativa 300mg	T308KHS	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall up to the point of sales	Syarikat Zulkifli Bamadhaj, Malaysia	01 February 2024
6	Vigouroxy	MAL06091569T	Herbs	052205V	The batch tested by NPRA found to contain Bile-Tolerant Gram Negative Bacteria above allowable limit	Degree III recall up to the point of sales	Nature's Grace (M) Sdn Bhd, Malaysia	01 February 2024
7	Apo-Mometasone Furoate Aqueous Nasal Spray 50 MCG/Metered Spray	MAL18016032AZ	Mometasone furoate 50mcg/ metered spray	TZ2389	Potential presence of Burkholderia cepacia complex (BCC) in the affected batch.	Voluntary recall up to the point of sales	Pharmaforte (Malaysia) Sdn. Bhd.	21 February 2024
8	Hyomide Tablet 10mg	MAL05101675AZ	Hyoscine butylbromide 10mg	2107056	Failure of related substances (tropic acid) assay test during stability study programme.	Voluntary recall up to the point of sales	Duopharma Maufacturing (Bangi) Sdn Bhd	13 March 2024
9	Listra Habbasauda 500mg Capsules	MAL16060013TC	Nigella sativa semen powder 500mg	TAAAZZAAALB 027-023	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall up to the point of sales	Bina Mutiara Global Sdn Bhd, Malaysia	14 March 2024
10	viTasential Chlorophyllin Plus Liquid	MAL18026028N	Sodium Copper Chlorophyllin 90mg Spirulina (Spirulina platensis) 10mg Chlorella (Chlorella vulgaris) Concentrate 10mg	VCP0822001	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall up to the point of sales	Sweet Heart Food Industries Sdn Bhd	14 March 2024
11	Hb" Well Capsule	MAL16060026TC	Herbs	23D1851	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall up to the point of sales	Metro Signature Sdn Bhd	14 March 2024
12	Wai Yoen Gold Brand Wu Jin Wan (Big Pill)	MAL21026053T	Herbs	03238A	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall up to the point of sales	Nutri-Home Pharmaceutical Industries Sdn Bhd	25 April 2024
13	Vivital Pharma Zivron Capsule	MAL16090042TC	Herbs	M005C23C	The batch tested by NPRA found to contain Bile- Tolerant Gram Negative Bacteria above allowable limit	Degree III recall up to the point of sales	Ligno & Us Sdn Bhd	25 April 2024
14	Provin-C Capsule	MAL21086075T	Herbs	2306C0517	The batch tested by NPRA found to contain Total Yeasts and Moulds Count above the allowable limit	Degree III recall up to the point of sales	Thiallan Bioherbs Sdn Bhd	25 April 2024
15	Ferrocyte Tablet 50mg	MAL19920395XZ	Ferric sodium citrate 50mg	1) 19A01S 2) 1ZA01S 3) 225A01S 4) 22XA01S 5) 231A01S 6) 235A01S 7) 237A01S 8) 242A01S	Out of specification for dissolution test at 12 months stored at 30°C/75% RH during annual stability study for batch 22XA01S	Voluntary recall up to the point of sales	Eisai (Malaysia) Sdn Bhd	23 May 2024
16	Pantoprazole Sandoz 40mg Powder for Solution For Injection	MAL14125125AZ	Pantoprazole Sodium Sesquihydrate 40mg	NS0719	Formation of visible particles after reconstitution. The particles identification revealed to be a complex of Pantoprazole API adsorbed on siloxane/ silicone particles.	Voluntary recall up to the point of sales	Sandoz Products Malaysia Sdn Bhd	10 June 2024
17	Ilium Ketamil Injection	MAL15070027HA (for use in animals)	Ketamine Hydrochloride 100mg/mL	240130B	Reports of crystallization in a small number of vials for particular batch (240130B) as informed by the product manufacturer.	Voluntary recall up to the point of sales	Delfi Marketing Sdn. Bhd.	14 June 2024
18	Shanghai Brand Ke Ou Du Tong San	MAL21096093TC	Herbs	SW32-003	The batch tested by NPRA found to contain Cadmium above the allowable limit	Degree II recall up to the point of sales	Kheng Heng Medical (M) Sdn Bhd, Malaysia	14 June 2024
19	Dat's San Hong Yoke Wong (Syrup)	MAL20012968TC	Herbs	M0606T06	The batch tested by NPRA found to contain Total Yeast and Moulds Count above the allowable limit	Degree III recall up to the point of sales	Tat Seo Health Factory Plt, Malaysia	14 June 2024
20	Tanamera Lemongrass and Ginger Herbal Tea	MAL16085043TC	Cymbopogon citratus (caulis) 1g Zingiber officinale (rhizome) 1g	23A02	The batch tested by NPRA found to contain Cadmium above the allowable limit	Degree II recall up to the point of sales	Tanamera Tropical Spa Sdn Bhd, Malaysia	14 June 2024
21	HLP Raven Enema	MAL06011891XC	Glycerin 25% v/v Sodium Chloride 15% w/v	LR01A01	The batch tested by NPRA had failed physical appearance test	Degree III recall up to the point of sales	Sew Cheong Corporation Sdn Bhd, Malaysia	14 June 2024
22	OK Kacip Fatimah Plus 500mg	MAL16040024T	Multiple active ingredients	A23024979	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall up to the point of sales	Perniagaan Orang Kampung Sdn. Bhd.	14 Jun 2024
23	Queen Jelly	MAL06011765T	Royal jelly 228mg	230701	The batch tested by NPRA found to contain Cadmium above the allowable limit	Degree II recall up to the point of sales	Yi Wang Honey Garden (M) Sdn Bhd, Malaysia	18 July 2024
24	Megalive NutriFer Capsule	MAL18096093NC	Iron pyrophosphate 230mg (equivalent to 17.94mg Iron) Folic acid 0.9mg Vitamin C 50mg Vitamin B12 0.06mg Copper gluconate 14.28mg (equivalent to 2mg Copper)	DD0206	The batch tested by NPRA had failed assay test for Folic Acid	Degree III recall up to the point of sales	Megalive BioSciences Sdn Bhd, Malaysia	18 July 2024
25	Hurix’s Gamat Plus Syrup	MAL21036096TC	Herbs	• 100mL Syrup Batch Number: • S050 231101 • S050 231201 • S050 231202 • S050 240101 • S050 240102 • S050 240103 • S050 240104	Recalls made following several complaints received by the company about the syrup appeared to be foamy after opening the cap which may indicates spoilage.	Voluntary recall up to the point of sales	Jin Bin Corporation Sdn. Bhd.	25 July 2024
26	Hurix’s Sirap Ubat Batuk Untuk Kanak-Kanak	MAL20033451TC	Herbs	• 60mL Syrup Batch Number: • S009 231101 • S009 231102 • S009 231201 • S009 231202 • S009 240101 • S009 240201	Recalls made following several complaints received by the company about the syrup appeared to be foamyafter opening the cap which may indicates spoilage.	Voluntary recall up to the point of sales	Jin Bin Corporation Sdn. Bhd.	25 July 2024
27	Powerlife Turmeric Zingiber Ginkgo with Piper Nigrum Tablet	MAL21026076TC	Herbs	DF0147 DF0285	The colour of the tablets is different from the registered specification.	Voluntary recall up to the point of sales	Powerlife (M) Sdn. Bhd.	22 August 2024
28	Actimol Suspension 250mg/5mL	MAL20046151XZ	Paracetamol	5031695	The assay test for active pharmaceutical ingredient (paracetamol) conducted on the retention sample for batch 5031695 revealed out of specification results.	Voluntary recall up to the point of sales	Idaman Pharma Manufacturing Sdn. Bhd.	27 August 2024
29	Traditional Hou Tsao San	MAL05092424T	Multiple active ingredients	2311-23L05	The batch tested by NPRA found to contain cadmium above the specification limit	Degree III recall up to the point of sales	Ban Kah Chai Pharmaceutical Sdn. Bhd.	06 September 2024
30	Ban Kah Chai Gold Brand Cordyceps Luo Han Guo Cough Syrup Plus	MAL07101292TC	Herbs	BN2404/23 BN2405/23 BN2401/24 BN2402/24	This recall is being carried out following an out-of- specification result for the volume test conducted on the affected batch.	Voluntary recall at the point of sub-distributor (wholesaler)	Ban Kah Chai Pharmaceutical Sdn. Bhd., Malaysia	4 October 2024
31	Pharmaniaga Enalapril Tablet 5mg	MAL20034480AZ	Enalapril Maleate 5mg	5022938	Out-of-specification result for the product’s dissolution and related substances test during stability study.	Voluntary recall up to the point of sales	Pharmaniaga Manufacturing Berhad	04 October 2024
32	Pharmaniaga Ephedrine Hydrochloride 30 mg/mL Injection	MAL19961320AZ	Ephedrine Hydrochloride 30mg/mL	5032011	This recall is being conducted due to the incorrect expiry date found on the ampoules label of the product.	Voluntary recall up to the point of sales	Pharmaniaga Lifescience Sdn. Bhd	16 October 2024
33	Caslot Tablets 25mg	MAL05090004AZ	Carvedilol 25mg	22010014	This recall is being conducted due to an out-of-specification result for the product's dissolution test during stability study.	Voluntary recall up to the point of sales	Ranbaxy (Malaysia) Sdn. Bhd.	18 October 2024
34	Ubat Akar-Akar Teh Sejuk Cap Tan Ngan Lo 6G/ Bag	MAL19950944T	Multiple active ingredients	BCC021A	This recall is being conducted due to the batch tested and found to contain cadmium above allowable limit	Voluntary recall up to the point of sales	Wen Jiang Medical Industries Sdn Bhd	30 October 2024
35	Apo-Amitriptyline 10mg Tablet	MAL19984714ARZ	Amitriptylline Hydrochloride	TW2842	The recall is being carried out following the decision regarding the content of N-nitroso-nortriptyline (NNORT) reported by Health Canada for batch TF8586, TF8587 and TF8589. The additional batches (TW2842) are recalled as a precautionary measure.	Voluntary recall up to the point of sales	Pharmaforte (Malaysia) Sdn. Bhd.	30 October 2024
36	Tai Fong Headache & Toothache Capsule	MAL05051145TC	Multiple active ingredients	T1222C50	This recall is being conducted due to the batch tested and found to contain cadmium above allowable limit	Degree II recall up to the point of sales	Smart Wellmin Sdn Bhd	21 November 2024
37	Beprosalic Lotion	MAL20021135AZ	Betamethasone dipropianate 0.064% Salicylic acid/ 2-Hydroxybenzoic acid 2.0%	1) 03913408 2) 06665408 3) 05094408 4) 1167B308 5) 01512408	This recall is being conducted due to an out-of- specification result for content of active pharmaceutical ingredient and appearance during stability study.	Voluntary recall at the point of sub-distributor (wholesaler)	Hoe Pharmaceuticals Sdn. Bhd.	03 December 2024
38	Soluwax Ear Drops	MAL19911464X	Docusate sodium 0.5% w/v	1) 06635404 2) 05595404	This recall is being conducted due to an out-of- specification result for pH parameter during stability study.	Voluntary recall at the point of sub-distributor (wholesaler)	Hoe Pharmaceuticals Sdn. Bhd.	03 December 2024
39	Etoxib F.C. Tablet 60mg	MAL22076022AZ	Etoricoxib 60mg	TE210035	An out of specification result was observed in the physical appearance test at the 12-month point of the stability study.	Voluntary recall up to the point of sales	Medispec (M) Sdn. Bhd.	03 December 2024
40	YSP Allopurinol Tablet 300mg	MAL19992398AZ	Allopurinol 300mg	1) ALT3 2) IC005 3) IC006 4) IC007 5) IC008 6) IC009 7) ID010	This recall is being conducted due to an out-of-specification result for the product’s colour and appearance.	Voluntary recall up to the point of sales	Y.S.P. Industries (M) Sdn. Bhd.	10 December 2024
41	Fenadium Tablet 25mg	MAL19900395AZ	Diclofenac sodium 25mg	627-22001	This recall is being conducted due to an out-of-specification result for the product’s other unspecified impurities during stability study	Voluntary recall up to the point of sales	Sunward Pharmaceutical Sdn. Bhd.	20 December 2024

Last update : 07/07/2025

Year 2023

No	Product Name	Registration Number	Active Ingredients	Batch Number	Reason for Recall	Degree and Level of Recall	Registration Holder	Date of Recall
1	Storvas C 20mg tablet	MAL11060016AZ	Atorvastatin Calcium 20mg/tablet	19121372 20040326 21010027	Out of specification of “Any Individual Impurity” in Related Substance Test of the product	Voluntary recall at the point of sales	Ranbaxy (Malaysia) Sdn Bhd	06 January 2023
2	Storvas C 40mg tablet	MAL11060017AZ	Atorvastatin Calcium 40mg/tablet	19121375 20030269 19121378 20081033 20040372	Out of specification of “Any Individual Impurity” in Related Substance Test of the product	Voluntary recall at the point of sales	Ranbaxy (Malaysia) Sdn Bhd	16 January 2023
3	Hermosa Maca 500mg Chewable Tablet	MAL20086112TC	Radix Lepidium meyenii 500mg	T0121T01	The batch tested by NPRA found to contain Cadmium above allowable limit	Degree II recall at the point of sales	Ecorigin Plt	17 January 2023
4	Xetec Tablet 10mg	MAL20040625AZ	Cetirizine Dihydrochloride 10mg	XE 20L 001	The batch tested by NPRA failed dissolution test and found to contain any secondary peak and Total impurities above specification limit	Degree II recall at the point of sales	SM Pharmaceuticals Sdn Bhd	17 January 2023
5	Gabata 300 (Gabapentin Capsules USP 300mg)	MAL19016037AZ	Gabapentin 300mg	21145468 20141660	Out of specification for “Any other individual impurities” was reported during stability study testing	Voluntary recall at the point of sales	Ascend Laboratories Sdn. Bhd.	08 February 2023
6	Bravecto 1400mg Chewable tablet for large dogs	MAL20026086HAR	Fluralaner 1400mg Chewable Tablet	22M5075A01	Label incompliance	Voluntary recall at the point of sales	Intervet (M) Sdn. Bhd.	09 February 2023
7	Cap Gunting Chai Teck Sang Shui Gan Teh 12gm	MAL20116092TC	Multiple active ingredients (Herbs)	22A007	The batch tested by NPRA found to contain Total Aerobic Microbial Count, Total Yeasts and Moulds Count and Bile-Tolerant Gram Negative Bacteria above allowable limit	Degree III recall at the point of sales	Chai Teck Sang Medical Hall Sdn Bhd	28 February 2023
8	WHP Modified Lian Hua Qing Wen Capsule	MAL21056079T	Multiple active ingredients (Herbs)	220315	The batch tested by NPRA found to contain cadmium and lead above the allowable limit	Degree II recall at the point of sales	White Heron Pharmaceutical Sdn. Bhd.	28 February 2023
9	Actimol Suspension 250mg/5mL	MAL20046151XZ	Paracetamol	5026851	Out of specification for assay during accelerated and real time stability study testing	Voluntary recall at the point of sales	Idaman Pharma Manufacturing Sdn. Bhd.	17 March 2023
10	Duro-Tuss Regular Cough Liquid 1mg/mL Kenyataan Media KPK	MAL13025049ACZ	Pholcodine 1mg/1mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Inova Pharmaceuticals (Singapore) Pte Ltd (Incorporated in Singapore) Malaysia Branch	20 March 2023
11	Duro-Tuss Forte Cough Liquid 3mg/mL Kenyataan Media KPK	MAL13025050ACZ	Pholcodine 3mg/ 1mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Inova Pharmaceuticals (Singapore) Pte Ltd (Incorporated in Singapore) Malaysia Branch	20 March 2023
12	Duro-Tuss Expectorant Cough Liquid Kenyataan Media KPK	MAL13025051ACZ	Pholcodine 1mg /1mL Bromhexine HCl 0.8mg/ 1mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Inova Pharmaceuticals (Singapore) Pte Ltd (Incorporated in Singapore) Malaysia Branch	20 March 2023
13	Difflam Anti-Inflammatory Antibacterial Lozenges With Cough Suppressant Kenyataan Media KPK	MAL14075076ACZ	Pholcodine 5.5mg Benzydamine hydrochloride 1.5mg Cetylpyridinium Chloride 1.33mg	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Inova Pharmaceuticals (Singapore) Pte Ltd (Incorporated in Singapore) Malaysia Branch	20 March 2023
14	Russedyl Compound Linctus Kenyataan Media KPK	MAL14055155AZ	Pholcodine 5mg/ 5mL Phenylephrine Hydrochloride 10mg/ 5mL Promethazine Hydrochloride 3.6mg/ 5mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Pharmaniaga Manufacturing Berhad	20 March 2023
15	Promedyl Plus Linctus Kenyataan Media KPK	MAL20033514AZ	Pholcodine 10mg/ 5mL Chlorpheniramine Maleate 4mg/ 5mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Duopharma Marketing Sdn. Bhd.	20 March 2023
16	Pholcodyl Syrup Kenyataan Media KPK	MAL05072033AZ	Pholcodine 5mg/ 5mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Sunward Pharmaceutical Sdn. Bhd.	20 March 2023
17	Pholcodyl Forte Syrup Kenyataan Media KPK	MAL05072034AZ	Pholcodine 15mg/ 5mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Sunward Pharmaceutical Sdn. Bhd.	20 March 2023
18	Rhynacol F Syrup Kenyataan Media KPK	MAL08010750AZ	Pholcodine 15mg/ 5mL Triprolidene Hydrochloride 2.5mg/ 5mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Sunward Pharmaceutical Sdn. Bhd.	20 March 2023
19	Ducodin Forte Linctus 15mg/5mL Kenyataan Media KPK	MAL07101250AZ	Pholcodine 15mg/ 5mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Hovid Berhad	20 March 2023
20	Ducodin Linctus 5mg/5mL Kenyataan Media KPK	MAL07101251AZ	Pholcodine 5mg/ 5mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Hovid Berhad	20 March 2023
21	Tussedyl Forte Syrup 15mg/5mL Kenyataan Media KPK	MAL06121115AZ	Pholcodine 15mg/ 5mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Pahang Pharmacy Sdn. Bhd.	20 March 2023
22	Axcel Iridin Linctus Kenyataan Media KPK	MAL09020970AZ	Pholcodine 10mg/ 5mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Kotra Pharma (M) Sdn. Bhd.	20 March 2023
23	Axcel Iridin Plus Linctus Kenyataan Media KPK	MAL09051551AZ	Pholcodine 5mg/ 5mL Triprolidene Hydrochloride 1.25mg/ 5mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Kotra Pharma (M) Sdn. Bhd.	20 March 2023
24	Zyrtec-D Tablet	MAL06061671ARZ	Cetirizine dihydrochloride and Pseudoephedrine hydrochloride	321907	Packaging defect	Voluntary recall at the consumer level (end users)	GlaxoSmithKline Pharmaceutical Sdn. Bhd.	29 March 2023
25	Moxied CLV Injection 600mg	MAL20041268AZ	Amoxycillin sodium 500mg, Potassium clavulanate 100mg	APE204	Out of specification observed during routine viable environmental monitoring	Voluntary recall at the point of sales	SM Pharmaceuticals Sdn. Bhd.	05 May 2023
26	Moxied CLV Injection 1.2g	MAL20041269AZ	Amoxycillin sodium 1000mg, Potassium clavulanate 200mg	API101 API204	Out of specification observed during routine viable environmental monitoring	Voluntary recall at the point of sales	SM Pharmaceuticals Sdn. Bhd.	05 May 2023
27	Mesporin-1000 I.V. Vials	MAL20013996ACZ	Ceftriaxone	Z0027Z0054 Z0108Z0125 Z0108Z0133 Z0139Z0184	Detection of visible particles in the reconstituted powder	Voluntary recall at the point of sales	Mepharm (Malaysia) Sdn. Bhd.	17 May 2023
28	Eno Fruit Salt Lemon	MAL19962147XR	Sodium bicarbonate, Citric acid, Sodium carbonate	XT4E XT4G	The impacted batch may potentially be contaminated with foreign materials	Voluntary recall at the distributor level	GlaxoSmithKline Consumer Healthcare Sdn. Bhd.	14 June 2023
29	Ecort cream	MAL19913384AZ	Econazole nitrate 1% w/w and triamcinolone 0.1% w/w	23E1470	Label incompliance	Voluntary recall at the point of sales	Dynapharm (M) Sdn. Bhd.	23 June 2023
30	Holistica Coflix Liquid	MAL20116054TC	Multiple active ingredients (Herbs)	7228221221B	There is a risk of glass fragment present in the bottle of the product	Voluntary recall at the consumer level (end users)	Eldon Healthcare Sdn. Bhd.	27 June 2023
31	Sabril 500mg Tablet	MAL19961357AZ	Vigabatrin 500mg	2991A	Detection of traces of tiapride originated from API vigabatrin	Voluntary recall at the point of sales	Sanofi-Aventis (Malaysia) Sdn. Bhd.	18 July 2023
32	Apo-acyclovir 400mg	MAL19984322ARZ	Acyclovir 400mg	TH6095	Impurity N-nitrosodimethylamine (NDMA) was found to exceed the acceptable intake limit in batch TH6095	Voluntary recall at the point of sales	Pharmaforte (Malaysia) Sdn. Bhd.	18 August 2023
33	Apo-acyclovir 800mg	MAL19984323ARZ	Acyclovir 800mg	TK3920 TF4478	Following voluntary recall of Apo-acyclovir 400mg (batch TH6095), as a precautionary measure, the company extends the recall to include two additional batches, TK3920 and TF4478	Voluntary recall at the point of sales	Pharmaforte (Malaysia) Sdn. Bhd.	18 August 2023
34	Alesone Cream	MAL20040076AZ	Mometasone furoate 0.1% w/w	E2104043	The batch tested by NPRA failed assay test for Mometasone furoate	Degree II recall at the point of sales	Prime Pharmaceutical Sdn Bhd	28 February 2023
35	Li Zhong Tang Extract Powder “Sheng Chang”	MAL10012457T	Herbs	CP3411210	The batch tested by NPRA found to contain Bile-Tolerant Gram Negative Bacteria above allowable limit	Degree III recall at the point of sales	Lifecare Essential Sdn Bhd	28 February 2023
36	Lartil Injection 1mL (12.5 mg/mL)	MAL19970964AZ	Prochlorperazine Mesylate 12.5mg /1 ml	212603L	The batch tested by NPRA found to contain related substances that were out of specification limit	Degree II recall at the point of sales	Duopharma (M) Sdn Bhd	28 February 2023
37	Ke Ou Du Tong San (kim Loong Brand)	MAL20000959TC	Herbs	2202-22B20	The batch tested by NPRA found to contain cadmium above allowable limit	Degree II recall at the point of sales	Jin Loong Enterprise Sdn Bhd	28 February 2023
38	Ubat akar-akar the sejuk cap Tan Ngan Lo 6g/bag	MAL19950944T	Herbs	BBCT721	The batch tested by NPRA found to contain cadmium above allowable limit	Degree II recall at the point of sales	Wen Jiang Medical Industries Sdn Bhd	28 February 2023
39	Chuan Pei Plus Powder Shanghai Brand	MAL20076113TC	Herbs	22B7002	The batch tested by NPRA found to contain Bile-Tolerant Gram-Negative Bacteria above allowable limit	Degree III recall at the point of sales	Keng Heng Medical (M) Sdn Bhd	11 April 2023
40	Skin-Fix cream	MAL15070014TC	Channa striatus extract 4g	22SC02	The batch tested by NPRA found to contain Total Yeasts and Moulds Count above allowable limit	Degree III recall at the point of sales	Truelifesciences Holdings Sdn Bhd	11 April 2023
41	Throat Medicated Powder	MAL05023417T	Herbs	073220401	The batch tested by NPRA found to contain cadmium and lead above allowable limit	Degree II recall at the point of sales	Herbal Land Manufacturing Sdn Bhd	11 April 2023
42	Nutri-Home Chin Choo Watermelon Frost Plus 2.2gm	MAL20001664T	Herbs	09208A	The batch tested by NPRA found to contain cadmium and Total Aerobic Microbial Count above allowable limit	Degree II recall at the point of sales	Nutri-Home Pharmaceutical Industries Sdn Bhd	11 April 2023
43	Golf Tong Jin Wan	MAL05121297T	Herbs	22B8010	The batch tested by NPRA found to contain cadmium above allowable limit	Degree II recall at the point of sales	Shanghai Chatlin Pharmaceutical Company	14 July 2023
44	Musclesmooth Herbal Plaster	MAL10100092T	Herbs	MUPUURA001	The batch tested by NPRA found to contain cadmium above allowable limit	Degree II recall at the point of sales	Sun Ten Pharmaceutical Mfg (M) Sdn Bhd	14 July 2023
45	Yung Kien Ganoderma 2 capsules	MAL10120091T	Extract of Ganoderma tsugae fruit body 450mg	A2BH291	The batch tested by NPRA found to contain cadmium above allowable limit	Degree II recall at the point of sales	Shuang Hor Enterprise (M) Sdn Bhd	14 July 2023
46	Dynalexin dry syrup 125mg/5ml	MAL07031083AZ	Cephalexin monohydrate	22S2374	Packaging defect	Voluntary recall at the point of sales	Dynapharm (M) Sdn. Bhd	08 August 2023
47	Guo Ma Ba Bao San (Powder)	MAL19988658T	Herbs	BBS2302	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall at the point of sales	Shin Li Trading	24 August 2023
48	Phytosophy Phyto Chlorophyll Plus Liquid	MAL16070029T	Chlorophyll powder 120mg Chlorella pyrenoidosa 40mg Potassium sorbate 0.03%	PTC 1400	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall at the point of sales	PHHP Group Sdn Bhd	24 August 2023
49	Shafli Teh Herba Gaharu	MAL13115169T	Folium Aquilaria malaccensis 1.5g	GT1001-0323	The batch tested by NPRA found to contain Cadmium above allowable limit	Degree II recall at the point of sales	Shafli Lagenda Sdn Bhd	22 September 2023
50	Alfa-D 1.00mcg Capsule	MAL09061594X	Alfacalcidol 1.00 mcg	22E72 & 22E73	The assay for Alfacalcidol conducted on batch 22E72 & 22E73 was found to be out of specifications during real time stability study at 12 months point	Voluntary recall at the point of sales	Pahang Pharmacy Sdn Bhd	27 September 2023
51	Di Ann Du Tong San	MAL20032112T	Herbs	All batches	The batch tested by NPRA found to contain Total Aerobic Microbial Count (TAMC) above allowable limit	Degree III recall at the point of sales	Di Ann Trading	01 November 2023
52	Honesty Healthcare American Ginseng 300 mg capsule	MAL05051191TC	Radix Panax quinquefolium L. 300mg	220108	The batch tested by NPRA found to contain cadmium above allowable limit	Degree II recall at the point of sales	Conforer Medi-Care Enterprise	01 November 2023
53	Wykon Xiao Er Bao Yin San	MAL21116118TC	Herbs	WBY22L01E	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall at the point of sales	Wykon Medical Sdn Bhd	01 November 2023
54	IME-9 Tablets	MAL21016096T	Herbs	157	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall at the point of sales	Ayush 82 Resources	01 November 2023
55	Omiflu Capsule 75mg	MAL07090926AZ	Oseltamivir phosphate	200879L	Failure of organic impurities and assay test during stability study programme	Voluntary recall at the point of sales	Duopharma (M) Sdn Bhd	17 November 2023
56	Ekoplast Medicated Plaster	MAL21096001XC	Ginger oil 4% w/w Methyl salicylate 4% w/w Menthol 2.5% w/w Camphor 1.8% w/w	V2212008	The batch tested by NPRA failed assay test for Methyl Salicylate	Degree III recall at the point of sales	Ee Koh Enterprise Sdn Bhd	20 December 2023
57	Shou Hsing Brand BuYao Pill (small)	MAL16120044TC	Herbs	9171220722	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall at the point of sales	Chua Tongsan Sdn Bhd	20 December 2023
58	Greenherbs Cough with Honey for kids liquid	MAL16080050T	Herbs	9165221214	The batch tested by NPRA found to contain Total Aerobic Microbial Count and Total Yeasts and Moulds Count above allowable limit	Degree III recall at the point of sales	Biofact Life Sdn Bhd	20 December 2023
59	Makjun Seri Perisai	MAL20012966T	Herbs	SP220501	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall at the point of sales	Syarikat Mutiara	20 December 2023

Last update : 20/08/2024

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