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Products Recalled in 2025

S/N

 

Date recall was initiated

Recall Reference Number

Product Name/ Category

(click to view the report)

INN Name (s)

Batch Number (s)

Name of Manufacturer

Reasons for recall

Status

18.

15/05/2025

REC/2025/018

Topfoliferum Tablets

Ferrous Sulphate+ Folic Acid

240105, 240415

Liaoning Huarui Union Pharmaceutical Co., Ltd, China

Failure to comply with the specifications for the Assay test

Ongoing

17.

24/04/2025

REC/2025/017

S-prazo Capsules

Esomeprazole 40mg Capsules

SPZ404

Medico Remedies Limited, India

Product mix-up involving S-Prazo Batch No. SPZ404, wherein it was detected and confirmed that a strip of Levofloxacin 500mg tablet was found in a pack of Esomeprazole 40mg Capsules.

Ongoing

16.

24/04/2025

REC/2025/016

Lumidol Injection

Paracetamol 1000mg/100ml

CM4594007, CM4594008, CM4594009

KamlaAmrut Pharmaceutical LLP India

Color change of the product to black

Ongoing

15.

24/04/2025

REC/2025/015

Paragen Injection

Paracetamol 1% W/V

K4290027

KamlaAmrut Pharmaceutical LLP India

Color change of the product to black

Ongoing

14.

24/04/2025

REC/2025/014

Blink Injection

Paracetamol 1% W/V

CS4594005, CS4594004

KamlaAmrut Pharmaceutical LLP India

Color change of the product to black

Ongoing

13.

03/04/2025

REC/2025/013

Dawaflox DPS

Flucloxacillin 125mg/5ml

2301119, 2401188

Dawa Ltd, Kenya

Failure to comply with assay identified during long-term stability studies

Ongoing

12.

03/04/2025

REC/2025/012

Stopacid Suspension

Aluminium Hydroxide BP 120mg & Magnesium Trisilicate BP 250mg

2407199, 2407200, 2407201, 2407202

Dawa Ltd, Kenya

Failure to comply with the release assay limits of Aluminium Hydroxide (95%-105%)

Ongoing

11.

03/04/2025

REC/2025/011

Medopress Tablets

Methyldopa 250mg

221137, 230051, 230093, 230165

Cosmos Ltd, Kenya

Color change of the tablets

Ongoing

10.

21/03/2025

REC/2025/010

Oxytocin Injection

Oxytocin BP 10IU/ML

MOEIE-003

Laborate Pharmaceuticals India Ltd

Failure to comply with the specifications on related substances test

Ongoing

9.

19/03/2025

REC/2025/009

Topfoliferum Tablets

Ferrous Sulphate+ Folic Acid

240726

Liaoning Huarui Union Pharmaceutical co. Ltd, China

Color change, with some tablets becoming darker with black particles

Ongoing

8.

11/03/2025

REC/2025/008

Betamol Tablets

Paracetamol 500mg

01215PT

Sphinx Pharmaceuticals Ltd, Kenya

Out-of-Specification results on uniformity of weight

Ongoing

7.

11/03/2025

REC/2025/007

Medzol Tablets

Metronidazole 400mg

230940

Shanxi Xinyitong Pharmaceutical Co., Ltd, China

Out-of-Specification results on uniformity of weight

Ongoing

6.

11/03/2025

REC/2025/006

Metrosim Tablets

Metronidazole 200mg

003835

Africure Pharmaceuticals India Private Limited

Failure to comply with the specifications on friability test

Ongoing

5.

10/03/2025

REC/2025/005

Shaltoux Herbal Cough Syrup

Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium Citrate & Menthol

24011

Gopaldas Visram & Company Limited, India

Market complaints of presence particulate matter in the product

Ongoing

4.

07/02/2025

REC/2025/004

APC Tablets

Paracetamol 250mg, Aspirin 150mg & Caffeine 30mg

1223038

Biodeal Laboratories Ltd, Kenya

Out-of-Specification results on uniformity of weight

Ongoing

3.

16/01/2025

REC/2025/003

TBcide

Sodium Hypochlorite Solution

24052101A2 and 24052201A2

Kenya Medical Research Institute (KEMRI)

Lack of the characteristic color and smell and formation of brown crystals on the product packaging.

Ongoing

2.

06/01/2025

REC/2025/002

Flurasted 500 Injection

5-Fluorouracil

HHP2401

Halsted Pharma Private Limited, India

Detection of particles in the product.

Ongoing

1.

03/01/2025

REC/2025/001

Bisotrol Tablets

Bisoprolol 5mg

JJI023002

Ipca Laboratories Limited, India

Out of specification (OOS) results observed in the Related Substances test of Bisotrol – 5 Tablet at 12M on 30C/75% stability conditions.

Ongoing