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.
|
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 |
|
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 |
|
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 |
Neupogen 30MIO 0.3mg/ml Vial |
MAL19921256AZ |
Recombinant Human Granulocyte Colony-stimulating Factor (Filgrastim) |
|
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 |
|
17 |
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 |
|
18 |
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 |
|
19 |
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 |
|
20 |
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 |
|
21 |
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 |
|
22 |
Vigouroxy |
MAL06091569T |
Multiple active ingredients |
062409V |
Batch showed cadmium assay is above allowable limit. |
Voluntary recall up to the point of sales |
Nature's Grace (M) Sdn. Bhd. |
29 May 2025 |
|
23 |
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 |
|
24 |
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 |
|
25 |
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 |
|
26 |
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 |
|
27 |
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 |
|
28 |
Teleact Tablets 80mg |
MAL13015032AZ |
Telmisartan |
|
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 |
|
29 |
Betanor 24mg Tablet |
MAL14075064AZ |
Betahistine Dihydrochloride |
|
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 |
|
30 |
Minyak Angin Orang Satu Mata |
MAL05121191X |
|
BBL908 |
The batch tested by NPRA was 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 |
|
31 |
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 |
|
32 |
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 |
|
33 |
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 |
|
34 |
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 |
|
35 |
NW Chlorhexidine Gluconate 5%W/V Topical Solution |
MAL18046124XZ |
Chlorhexidine Gluconate |
|
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 |
|
36 |
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 |
|
37 |
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 |
|
38 |
Soft Flow SC Low Calcium (2.5MEQ/L) Peritoneal Dialysis Solution With Dextrose 2.5% W/V |
MAL18116040AZ |
Multiple active ingredients |
|
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. |
Degree III recall up to the level of hospital and consumers |
Peritone Health Sdn. Bhd. |
25 August 2025 |
Last update : 22/09/2025








