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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 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

  1. Nigella sativa
  2. 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

  1. Panax notoginseng
  2. 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

Neupogen 30MIO 0.3mg/ml Vial

MAL19921256AZ

Recombinant Human Granulocyte Colony-stimulating Factor (Filgrastim)

  1. 1155389
  2. 1159120
  3. 1161429
  4. 1163920
  5. 1164773
  6. 1168146
  7. 1168467
  8. 1170219
  9. 1177267
  10. 1179510
  11. 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

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

  1. MLF0133A
  2. 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

29

Betanor 24mg Tablet

MAL14075064AZ

Betahistine Dihydrochloride

  1. 2410108
  2. 2410109
  3. 2411059
  4. 2501072
  5. 2501073
  6. 2502085
  7. 2502086
  8. 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

30

Minyak Angin Orang Satu Mata

MAL05121191X

  1. Camphor
  2. Eucalyptus Oil
  3. Menthol Crystal
  4. Methyl Salicylate

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

  1. NW24M26423
  2. 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

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

  1. P4J034-1A12
  2. P4J034-1A13
  3. P4J035-1A11
  4. P4J035-1A12
  5. P4J035-1A13
  6. P4J036-1A11
  7. P4J037-1A11
  8. P4J037-1A12
  9. P4J038-1A11
  10. P4J038-1A12
  11. P4J039-1A11
  12. P4J039-1A12
  13. P4J039-1A13
  14. P4J040-1A11
  15. P4J040-1A12
  16. P4J041-1A11
  17. P4J041-1A12
  18. P4J041-1A13
  19. P4J042-1A11
  20. P4J042-1A12
  21. P4J043-1A11
  22. P4J043-1A12
  23. P4J043-1A13
  24. P4J044-1A11
  25. P4J044-1A12
  26. P4J044-1A13
  27. P4J045-1A11
  28. P4J045-1A12
  29. P4J046-1A11
  30. P4J046-1A12
  31. P4J047-1A11
  32. P4J047-1A12
  33. P4J047-1A13
  34. P4K001-1A11
  35. P4K001-1A12
  36. P4K002-1A11
  37. P4K002-1A12
  38. P4K002-1A13
  39. P4K003-1A11
  40. P4K003-1A12
  41. P4K004-1A11
  42. P4K004-1A12
  43. P4K004-1A13
  44. P4K005-1A11
  45. 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.

Degree III recall up to the level of hospital and consumers

Peritone Health Sdn. Bhd.

25 August 2025

 

Last update : 22/09/2025

Year 2024
Year 2023

 

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

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  • Last Modified: Thursday 04 December 2025, 16:14:20.
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