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 |
|
45. |
29/12/2025 |
REC/2025/045 |
Methyldopa 250mg |
BPL.221138 |
Cosmos Limited, Kenya, |
Presence of grey spots on the tablet surface |
Concluded |
|
|
44. |
01/12/2025 |
REC/2025/044 |
Paracetamol 500mg |
BPL.83730.
|
Laboratory and Allied Ltd, Kenya
|
Brown visible contaminants were observed |
Concluded |
|
|
43. |
23/12/2025 |
REC/2025/043 |
Cefalexin powder for oral suspension |
88579 |
Laboratory and Allied Ltd, Kenya |
Brown visible contaminants were observed |
Concluded |
|
|
42. |
23/12/2025 |
REC/2025/042 |
Azithromycin oral suspension |
BPL915A |
Biopharma ltd, Kenya |
Product did not meet the required specifications for the pH and Assay test |
Concluded |
|
|
41. |
23/12/2025 |
REC/2025/041 |
Chlorpromazine Hcl |
83315 83863 |
Laboratory and Allied Ltd, Kenya |
The tablets were observed to be capping |
Concluded |
|
|
40. |
23/12/2025 |
REC/2025/040 |
Albendazole 200mg/5ml |
250407 |
Dinlas Pharma (Africa) Ltd, Kenya |
Product did not comply with the required specifications with reference to the deliverable volume test |
Concluded |
|
|
39. |
23/12/2025 |
REC/2025/039 |
Cefuroxime Axetil for Oral Suspension 125mg/5ml |
44B5411 |
Relax Biotech Pvt. Ltd., India |
Product did not meet specifications for the Assay test |
Concluded |
|
|
38. |
23/12/2025 |
REC/2025/038 |
Ciprofloxacin |
88224 84225 84659 84660 |
Laboratory & Allied Ltd, Kenya |
Brown spots observed on the tablets |
Concluded |
|
|
37. |
23/12/2025 |
REC/2025/037 |
Azithromycin Dihydrate USP equivalent Azithromycin Dihydrate USP equivalent |
ZIU022404
|
Saga Laboratories, India |
Product did not meet the specification for assay test |
Concluded |
|
|
36. |
02/12/2025 |
REC/2025/036 |
Papain, Fungal Diastase, and Simethicone |
P1024042 |
Gepach International, India |
Bulging observed in the strip packs |
Concluded |
|
|
35. |
14/11/2025 |
REC/2025/035 |
Carvedilol 12.5 mg |
GBC013001 |
Ipca Laboratories Limited, India |
Assay results of 94.7% against the specification limit of 95.0% to 105.0% at 24-month time point at storage condition 30°C/75% RH |
Concluded |
|
|
34. |
07/11/2025 |
REC/2025/034 |
Ibuprofen and Paracetamol |
0424097, 0824011 |
Biodeal Laboratories Ltd, Kenya |
Failure to comply with the specifications for pH and Assay test for Paracetamol |
Concluded |
|
|
33. |
28/10/2025 |
REC/2025/033 |
Magnesium Sulfate 50% W/V |
85055, 86718, 88683, 88688, 88690, 89181, 89182, and 89183 |
Laboratory & Allied Ltd, Kenya |
Mislabeling. Dosage strength on the ampoule indicated as 0.5mg/ml instead of 0.5g/ml. |
Concluded |
|
|
32. |
30/09/2025 |
REC/2025/032 |
Amoxicillin |
01599AMS |
Sphinx Pharmaceuticals Ltd, Kenya |
Light yellow to brown powder observed, with brown particles adhering to the base of the bottle. |
Concluded |
|
|
31. |
30/09/2025 |
REC/2025/031 |
Cloxacillin/Ampicillin |
00066CXS |
Sphinx Pharmaceuticals Ltd, Kenya |
Brown particles were observed dispersed throughout the powder and at the base of the bottle. |
Concluded |
|
|
30. |
22/08/2025 |
REC/2025/030 |
Paracetamol |
24GEF041 |
Globela Pharma Pvt. Ltd |
Tablets colour change to brown |
Concluded |
|
|
29. |
20/08/2025 |
REC/2025/029 |
Betamethasone/ Dexchlorpheniramine Maleate |
BPL783A, BPL409A |
Biopharma Ltd |
Failure to comply with identification by HPLC test for betamethasone and assay for both betamethasone and dexchlorpheniramine Maleate |
Concluded |
|
|
28. |
20/08/2025 |
REC/2025/028 |
Paracetamol |
240831, 240181, 240158, 230215, 240051, 230172 and 240213 |
Dinlas Pharma |
Particulate matter in solution |
Concluded |
|
|
26. |
20/08/2025 |
REC/2025/026 |
Azithromycin 200mg/5ml |
BPL 539A |
Biopharma Ltd |
An off-white to light yellow viscous mobile homogenous suspension was observed against the specification of an orange, viscous mobile homogenous suspension |
Concluded |
|
|
25. |
17/07/2025 |
REC/2025/025 |
Albendazole 200mg/5ml |
230359 |
Dinlas Pharma (Africa) Ltd, Kenya |
Failure to comply with deliverable volume test |
Concluded |
|
|
24. |
17/07/2025 |
REC/2025/024 |
Ondansetron 8mg/4ml |
ZOU-2401 |
Systochem Laboratories Limited, India |
Failure to comply with the specifications of physical appearance |
Concluded |
|
|
23. |
17/07/2025 |
REC/2025/023 |
Enalapril 5mg |
T24A016 |
Zain Pharma Ltd, Kenya |
Failure to comply with the specifications for hardness test |
Concluded |
|
|
22. |
15/07/2025 |
REC/2025/022 |
Phenytoin 100mg |
0724016 |
Biodeal Laboratories Ltd, Kenya |
Color change of the tablets |
Concluded |
|
|
21. |
09/07/2025 |
REC/2025/021 |
Paracetamol 250mg and Paracetamol 125mg Suppository |
28426, 28579, 26906, 27286, 27339, 27342, 27846, 27836, 28422, 28424, 28420, 28458, 27670, 27672, 27291, 27343, 27674, 27821, 27822 |
RubiePharm Arzneimittel GmbH, Germany |
Packaging damages (leakages) of blisters |
Concluded |
|
|
20. |
10/06/2025 |
REC/2025/020 |
Paracetamol BP 20mg, Caffeine Anhydrous BP 50mg, Aspirin BP 40 mg |
2311024 and 2406159 |
Beta Healthcare International Ltd, Kenya |
Failure to comply with the specifications for the Assay test |
Concluded |
|
|
19 |
03/06/2025 |
REC/2025/019 |
Ibuprofen and Paracetamol |
0623005 |
Biodeal Laboratories Ltd, Kenya |
Failure to comply with the specifications for pH and Assay tests |
Concluded |
|
|
18. |
15/05/2025 |
REC/2025/018 |
Ferrous Sulphate+ Folic Acid |
240105, 240415 |
Liaoning Huarui Union Pharmaceutical Co., Ltd, China |
Failure to comply with the specifications for the Assay test |
Concluded |
|
|
17. |
24/04/2025 |
REC/2025/017 |
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. |
Concluded |
|
|
16. |
24/04/2025 |
REC/2025/016 |
Paracetamol 1000mg/100ml |
CM4594007, CM4594008, CM4594009 |
KamlaAmrut Pharmaceutical LLP India |
Color change of the product to black |
Concluded |
|
|
15. |
24/04/2025 |
REC/2025/015 |
Paracetamol 1% W/V |
K4290027 |
KamlaAmrut Pharmaceutical LLP India |
Color change of the product to black |
Concluded |
|
|
14. |
24/04/2025 |
REC/2025/014 |
Paracetamol 1% W/V |
CS4594005, CS4594004 |
KamlaAmrut Pharmaceutical LLP India |
Color change of the product to black |
Concluded |
|
|
13. |
03/04/2025 |
REC/2025/013 |
Flucloxacillin 125mg/5ml |
2301119, 2401188 |
Dawa Ltd, Kenya |
Failure to comply with assay identified during long-term stability studies |
Concluded |
|
|
12. |
03/04/2025 |
REC/2025/012 |
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%) |
Concluded |
|
|
11. |
03/04/2025 |
REC/2025/011 |
Methyldopa 250mg |
221137, 230051, 230093, 230165 |
Cosmos Ltd, Kenya |
Color change of the tablets |
Concluded |
|
|
10. |
21/03/2025 |
REC/2025/010 |
Oxytocin BP 10IU/ML |
MOEIE-003 |
Laborate Pharmaceuticals India Ltd |
Failure to comply with the specifications on related substances test |
Concluded |
|
|
9. |
19/03/2025 |
REC/2025/009 |
Ferrous Sulphate+ Folic Acid |
240726 |
Liaoning Huarui Union Pharmaceutical co. Ltd, China |
Color change, with some tablets becoming darker with black particles |
Concluded |
|
|
8. |
11/03/2025 |
REC/2025/008 |
Paracetamol 500mg |
01215PT |
Sphinx Pharmaceuticals Ltd, Kenya |
Out-of-Specification results on uniformity of weight |
Concluded |
|
|
7. |
11/03/2025 |
REC/2025/007 |
Metronidazole 400mg |
230940 |
Shanxi Xinyitong Pharmaceutical Co., Ltd, China |
Out-of-Specification results on uniformity of weight |
Concluded |
|
|
6. |
11/03/2025 |
REC/2025/006 |
Metronidazole 200mg |
003835 |
Africure Pharmaceuticals India Private Limited |
Failure to comply with the specifications on friability test |
Concluded |
|
|
5. |
10/03/2025 |
REC/2025/005 |
Diphenhydramine Hydrochloride, Ammonium Chloride, Sodium Citrate & Menthol |
24011 |
Gopaldas Visram & Company Limited, India |
Market complaints of presence particulate matter in the product |
Concluded |
|
|
4. |
07/02/2025 |
REC/2025/004 |
Paracetamol 250mg, Aspirin 150mg & Caffeine 30mg |
1223038 |
Biodeal Laboratories Ltd, Kenya |
Out-of-Specification results on uniformity of weight |
Concluded |
|
|
3. |
16/01/2025 |
REC/2025/003 |
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. |
Concluded |
|
|
2. |
06/01/2025 |
REC/2025/002 |
5-Fluorouracil |
HHP2401 |
Halsted Pharma Private Limited, India |
Detection of particles in the product. |
Concluded |
|
|
1. |
03/01/2025 |
REC/2025/001 |
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. |
Concluded |