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 | Ongoing | |
44. | 01/12/2025 | REC/2025/044 | Paracetamol 500mg | BPL.83730.
| Laboratory and Allied Ltd, Kenya
| Brown visible contaminants were observed | Ongoing | |
43. | 23/12/2025 | REC/2025/043 | Cefalexin powder for oral suspension | 88579 | Laboratory and Allied Ltd, Kenya | Brown visible contaminants were observed | Ongoing | |
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 | Ongoing | |
41. | 23/12/2025 | REC/2025/041 | Chlorpromazine Hcl | 83315 83863 | Laboratory and Allied Ltd, Kenya | The tablets were observed to be capping | Ongoing | |
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 | Ongoing | |
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 | Ongoing | |
38. | 23/12/2025 | REC/2025/038 | Ciprofloxacin | 88224 84225 84659 84660 | Laboratory & Allied Ltd, Kenya | Brown spots observed on the tablets | Ongoing | |
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 | Ongoing | |
36. | 02/12/2025 | REC/2025/036 | Papain, Fungal Diastase, and Simethicone | P1024042 | Gepach International, India | Bulging observed in the strip packs | Ongoing | |
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 | Ongoing | |
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 | Ongoing | |
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. | Ongoing | |
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 | Ongoing | |
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 | Ongoing | |
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 | Ongoing | |
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 |