List of Recalled Products — JULY 2026

Published recalls only. Click View for full details and recall letter.

Total: 124 Class I: 35 Class II: 76 Class III: 9

SN	File / Recall No.	Medicine Name	Manufacturer	Batch No.	Recall Level	Class	Safety Issue	Reporter	Date of Recall
1	DD/PVCT/1164/FDA/2025	Aspirine vitammin C 330MG/200 mg BN: B6224, Exp. 08/2026	UPSA SAS, France	B6224	Consumer	Class II	Color change from white to brown color	PHARMACURE PHARMACY	23/04/2025
2	Ref No 011/RMS/CEO/2025	Chlorpheniramine (Chaleate) 4 mg tablets BN: 84936 exp. 10/ 2026	Lab & Allied Ltd, Kenya	84936	Retail	Class II	the product failed to comply with uniformity of content and assay test specifications.	RMS HQ	27/01/2025
3	Ref No 007/RMS/CEO/2025	Dix (Digoxin Tablets 0.25 mg) BN: T36028 exp. in 10/2026	Agog Pharma Ltd	T36028	Retail	Class II	the product failed to comply with uniformity of content and assay (overdosed) test specifications	RMS HQ	03/01/2025
4	Ref No.:FDISM/PVSM/5429/FDA/2023	Fluconazole 200mg tablets BN: 5810022, Exp: 31/08/2025	Universal Corporation Ltd/ Kikuyu	5810022	Retail	Class II	The pink tablets displayed white discloration	Universal Corporation Ltd/ Kikuyu	29/12/2023
5	Ref No.:FDISM/PVSM/5429/FDA/2023	Fluconazole 200mg tablets BN: 5811390, Exp: 31/08/2025	Universal Corporation Ltd/ Kikuyu	5811390	Retail	Class II	The pink tablets displayed white discloration	Universal Corporation Ltd/ Kikuyu	29/12/2023
6	Ref No.:FDISM/PVSM/5429/FDA/2023	Fluconazole 200mg tablets BN: 5810316, Exp: 31/01/2025	Universal Corporation Ltd/ Kikuyu	5810316	Retail	Class II	The pink tablets displayed white discloration	Universal Corporation Ltd/ Kikuyu	29/12/2023
7	Ref No.:FDISM/PVSM/5429/FDA/2023	Fluconazole 200mg tablets, BN: 5810315, Exp: 31/01/2025	Universal Corporation Ltd/ Kikuyu	5810315	Retail	Class II	The pink tablets displayed white discloration	Universal Corporation Ltd/ Kikuyu	29/12/2023
8	Ref.No.: FDISM/PVSM/3928/FDA/2023	Amoxiclav denk 1000/125mg powder for oral suspension BN: 27298, Exp: 06/2025	PenCef Pharma GmbH/ Berlin	—	Retail	Class II	Ongoing stability study and associated investigation indicated "change in appearance of individual sachets of AmoxiClav-Denk 1000/125 mg powder resulting in deviation of clavulanic acid content		18/09/2023
9	Ref.No.: FDISM/PVSM/3928/FDA/2023	Amoxiclav denk 1000/125mg powder for oral suspension BN: 27297, Exp: 06/2025	PenCef Pharma GmbH/ Berlin	—	Retail	Class II	Ongoing stability study and associated investigation indicated "change in appearance of individual sachets of AmoxiClav-Denk 1000/125 mg powder resulting in deviation of clavulanic acid content		18/09/2023
10	Ref.No.: FDISM/PVSM/3928/FDA/2023	Amoxiclav denk 1000/125mg powder for oral suspension BN:27296, Exp: 06/2025	PenCef Pharma GmbH/ Berlin	—	Retail	Class II	Ongoing stability study and associated investigation indicated "change in appearance of individual sachets of AmoxiClav-Denk 1000/125 mg powder resulting in deviation of clavulanic acid content		18/09/2023
11	Ref No.:FDISM/PVSM/2326/FDA/2023	Gastro-resistant sodium valproate tablets BP 500mg BN: All Exp. All	4 Care Lifescience Pvt Ltd/ India	—	Retail	Class II	The tablets become sami-solid and cracked	Kirehe, Nyanza,Shyira,Mugonero,rwinkwavu, Gisenyi Hospitals	30/05/2023
12	Ref No.:FDISM/PVSM/2326/FDA/2023	Gastro-resistant sodium valproate tablets BP 300mg BN: All Exp. All	4 Care Lifescience Pvt Ltd/ India	—	Retail	Class II	The tablets become sami-solid and cracked	Kirehe, Nyanza,Shyira,Mugonero,rwinkwavu, Gisenyi Hospitals	30/05/2023
13	Ref No.:FDISM/PVSM/419/FDA/2023	Spamox oral suspension (amoxicillin 125 mg/ 5ml) BN: All Exp. All	Sparsh Bio- Tech Pvt Ltd/ India	—	Retail	Class II	Clumping of the powder for suspension	Murunda Hospital	27/01/2023
14	Ref No.:FDISM/PVSM/419/FDA/2023	Spamox oral suspension (amoxicillin 250 mg/ 5ml) BN: All Exp. All	Sparsh Bio- Tech Pvt Ltd/ India	—	Retail	Class II	Clumping of the powder for suspension	RMS Ltd	27/01/2023
15	Ref No.:FDISM/PVSM/251/FDA/2023	Hyoscine Butylbromide tablets BP 10mg, BN: 22HB01, Exp. 03/2025	Morkash Pharmaceuticals Pvt Ltd/ India	—	Retail	Class II	Presence of cracks on the surface of tablets	RMS Ltd	18/01/2023
16	Ref No.:FDISM/PVSM/251/FDA/2023	Aminophylline tablets 100 MG USP, BN: 22AP01, Exp.03/2025	Morkash Pharmaceuticals Pvt Ltd/ India	—	Retail	Class II	Presence of mottling on the surface of tablet	RMS Ltd	18/01/2023
17	Ref No.: DIS/1987/FDA/2022	Amoxicillin oral Suspension BN: X0938 Exp. 05/2023	SPARSH BIO-TECH PVT Ltd/ INDIA	—	Retail	Class II	Clumping of the powder for suspension	RMS Ltd	29/04/2022
18	Ref No.: DIS/1987/FDA/2022	Amoxicillin oral Suspension BN: X0937 Exp. 05/2023	SPARSH BIO-TECH PVT Ltd/ INDIA	—	Retail	Class II	Clumping of the powder for suspension	RMS Ltd	29/04/2022
19	Ref No.: DIS/1987/FDA/2022	Amoxicillin oral Suspension BN: X0934 Exp. 05/2023	SPARSH BIO-TECH PVT Ltd/ INDIA	—	Retail	Class II	Clumping of the powder for suspension	RMS Ltd	29/04/2022
20	Ref No.: DIS/1987/FDA/2022	Amoxicillin oral Suspension BN: X0908 Exp. 11/2022	SPARSH BIO-TECH PVT Ltd/ INDIA	—	Retail	Class II	Clumping of the powder for suspension	RMS Ltd	29/04/2022
21	Ref No.: DIS/1987/FDA/2022	Metronidazole Vaginal Tablets 500mg BN:T15039; 08/2024	Agog Pharma Ltd., India	—	Retail	Class II	Presence of mottling on the surface of vaginal tablet	RMS Ltd	29/04/2022
22	Ref No.: DIS/1987/FDA/2022	Amoxicillin oral Suspension BN: X0939 Exp. 05/2023	SPARSH BIO-TECH PVT Ltd/ INDIA	—	Retail	Class II	Clumping of the powder for suspension	RMS Ltd	29/04/2022
23	Ref No.: DIS/1987/FDA/2022	Amoxicillin oral Suspension BN: X0940 Exp. 05/2023	SPARSH BIO-TECH PVT Ltd/ INDIA	—	Retail	Class II	Clumping of the powder for suspension	RMS Ltd	29/04/2022
24	Ref No.: DIS/1987/FDA/2022	Amoxicillin oral Suspension BN: X0941 Exp. 05/2023	SPARSH BIO-TECH PVT Ltd/ INDIA	—	Retail	Class II	Clumping of the powder for suspension	RMS Ltd	29/04/2022
25	Ref No.: DIS/1987/FDA/2022	Amoxicillin oral Suspension BN: X0942 Exp. 05/2023	SPARSH BIO-TECH PVT Ltd/ INDIA	—	Retail	Class II	Clumping of the powder for suspension	RMS Ltd	29/04/2022
26	Ref No.: DIS/5050/FDA/2021	ALBAMAS-400 (Albendazole tablets 400mg) MTE20007	Mascot Health Series Pvt. Ltd, Plot No. 78,80,Sec-6A, IIE, Sidcul, Haridwar-249403, Uttarakhand, India	—	Retail	Class II	change of tablet colour and most of tablets crumble upon unpacking from blisters	Escort Pharma Ltd	10/12/2021
27	DIS/046/FDA/2021	Aminosidine 250mg(Unibrol) BN:5806898 Mfd:09/2019,Exp date:08/2022	Universal corporation/Kenya	—	Retail	Class II	Color change for some tablet within blisters	IREME Pharmacy	01/12/2021
28	DIS/046/FDA/2021	Aminosidine 250mg(Unibrol) BN:5806675 Mfd:06/2019,Exp date:05/2022	Universal corporation/Kenya	—	Retail	Class II	Color change for some tablet within blisters	Client himself	01/12/2021
29	DIS/2100/FDA/2021	Nystatin oral suspension BP 100 000 IU/ml BN:2006004 , Mfd:06/2020, Exp:05/2022	DAWA Limited/ KENYA	—	Retail	Class II	More than 10 bottles were found with a solid lower sediment which is very difficult to shake to the homogeneous status, and several bottles seem to have developed microbial growths that led to the cloudy/misty appearance in the bottles	RMS Ltd	25/05/2021
30	DIS/1857/FDA/2021	Azithromycin dry powder for suspension (ZEROCIN ) BN:75363,Mfd:09/2019,Exp:08/2021	Laboratory&Allied Ltd./kenya	—	Retail	Class II	Caking of the powder in the bottom of the bottles causing poor flowability	Escort Pharma Ltd	25/05/2021
31	DIS/1851/FDA/2021	Amoxicillin 250mg capsule BN:MP18485A,Mfd:-,Exp:09/2021	MILAN LABORATORIES (INDIA) PVT. LTD	—	Retail	Class II	Presence of unidentified solid dark blue / black particles looking like foreign impurities that contaminated the formulation during production	RMS Ltd	25/05/2021
32	DIS/1853/FDA/2021	Hyoscine Butylbromide Injection BP 20mg/ml,3H20002,Mfd:08/2020,Exp:07/2022	Centurion Healthcare Private Limited	—	Retail	Class II	Particulate matter	RMS Ltd	25/05/2021
33	DIS/1441/FDA/2021	Unibrol(Aminosidine)250mg,BN:5805934,Mfd:02/2019,Exp:01/2022	Universal corporation/Kenya	—	Retail	Class II	Change of color for some tablet with yellow color instead of white color	Clients	28/04/2021
34	DIS/1257/FDA/2021	Telmisartan 40mg BN:FF9016,Mfd:06/2019,Exp:05/2022	Galaxy Pharmaceuticals/India	—	Retail	Class II	The tablet broken down easily	Mediasol Pharmacy	14/04/2021
35	DIS/1256/FDA/2021	AGOMYCIN Suspension (Erythromycin Estolate Oral Suspension 125mg/5ml),BN:L96013,Mfd:11/2019,Exp:10/2022	Agog Pharma Limited, India	—	Retail	Class II	Low level of Content of Erythromycin Estolate eq. to Erythromycin,36.476mgl5m1. while normal range should be 112.50 - 143.75mg15m\|,	RMS Ltd	14/04/2021
36	Ref No.:DIS/046/FDA/2021	Aminosidine 250mg(Unibrol) BN:5806898 Mfd:01/09/2019,Exp date:31/08/2022	Universal corporation/Kenya	—	Retail	Class II	Color change for some tablet within blisters	Aminadab Pharmacy/Musanze	12/01/2021
37	Ref No.:DIS/046/FDA/2021	Unibrol(Aminosidine)250mg,BN:5805934,Mfd:02/2019,Exp:01/2022	Universal corporation/Kenya	—	Retail	Class II	Change of color for some tablet with yellow color instead of white color	Clients	12/01/2021
38	Ref No.:DIS/046/FDA/2021	Unibrol(Aminosidine)250mg,BN:5807242,Mfd:02/2020,Exp:01/2023	Universal corporation/Kenya	—	Retail	Class II	Change of color for some tablet with yellow color instead of white color	Clients	12/01/2021
39	DIS/1164/RwandaFDA/2020	Benzyl penicillin procaine+DHS BN:MI12-12,Mfd:03/2019,Exp:03/2021	PUSHKIN LABORATORY LLC/Russia	—	Retail	Class II	Precipitation of the product with crystallization	Rwanda FDA inspection	06/12/2020
40	DIS/1164/RwandaFDA/2020	Benzyl penicillin procaine+DHS BN:MI12-11,Mfd:02/2019,Exp:02/2021	PUSHKIN LABORATORY LLC/Russia	—	Retail	Class II	Precipitation of the product with crystallization	Rwanda FDA inspection	06/12/2020
41	DIS/1164/RwandaFDA/2020	Benzyl penicillin procaine+DHS BN:MI12-10,Mfd:02/2019,Exp:02/2021	PUSHKIN LABORATORY LLC/Russia	—	Retail	Class II	Precipitation of the product with crystallization	Rwanda FDA inspection	06/12/2020
42	DIS/1164/RwandaFDA/2020	Benzyl penicillin procaine+DHS BN:MI12-09,Mfd:01/2019,Exp:01/2021	PUSHKIN LABORATORY LLC/Russia	—	Retail	Class II	Precipitation of the product with crystallization	Rwanda FDA inspection	06/12/2020
43	DIS/1164/RwandaFDA/2020	Benzyl penicillin procaine+DHS BN:MI12-08,Mfd:01/2019,Exp:01/2021	PUSHKIN LABORATORY LLC/Russia	—	Retail	Class II	Precipitation of the product with crystallization	Rwanda FDA inspection	06/12/2020
44	DIS/1164/RwandaFDA/2020	Benzyl penicillin procaine+DHS BN:MI12-07,Mfd:01/2019,Exp:06/2022	PUSHKIN LABORATORY LLC/Russia	—	Retail	Class II	Precipitation of the product with crystallization	Rwanda FDA inspection	06/12/2020
45	DIS/1164/RwandaFDA/2020	Benzyl penicillin procaine+DHS BN:MI12-06,Mfd:01/2019,Exp:01/2021	PUSHKIN LABORATORY LLC/Russia	—	Retail	Class II	Precipitation of the product with crystallization	Rwanda FDA inspection	06/12/2020
46	Ref.No.: DIS/2887/FDA/2020	Unibrol(Aminosidine)250mg,BN:586898,Mfd:09/2019,Exp:08/2022	Universal corporation/Kenya	—	Retail	Class II	Color change for some tablet within blisters	AMAYA PHARMACY	29/11/2020
47	DIS/1153/RwandaFDA/2020	Huureka Disinfectant	KEWS CORPORATION/SOUTH KOREA	—	Retail	Class II	Suspected poor quality product		06/11/2020
48	Ref.No: DIS/2419/FDA/2020	NEMCHEM Terminal Hand Sanitizer(Ethanol based),BN:0076,Mfd:20/03/2020,Exp:20/03/2022	NEM CHEM INTERNATIONAL	—	Retail	Class II	Alcohol content at low level	Rwanda FDA	25/10/2020
49	Ref.No.:DIS/2385/FDA/2020	Pure Skin Stay Safe Hand Sanitizer (Ethanol based) BN:001,Mfd:May 2020,Exp:April 2022	Africana Buffalo Ltd/Kigali,Gasabo	—	Retail	Class II	Alcohol content at low level	Rwanda FDA	21/10/2020
50	DIS/1877/FDA/2020	(Acaricide)Amitraz 12,5% EC	HebeiChengSheng Tang Animal Pharmaceuticals Co Ltd	—	Retail	Class II	Lack of storage condition and evaporation of the products	Rwanda FDA inspection	31/08/2020
51	DIS/1876/FDA/2020	Ivermectine injection 1% (BN:180617, EXP: 06/2021)	HebeiChengSheng Tang Animal Pharmaceuticals Co Ltd	—	Retail	Class II	Lack of storage condition on the labeling	Rwanda FDA inspection	31/08/2020
52	DIS/1876/FDA/2020	Novalgine injection 50% (BN 190729A , EXP07/2022)	HebeiChengSheng Tang Animal Pharmaceuticals Co Ltd	—	Retail	Class II	Lack of storage condition on the labeling	Rwanda FDA inspection	31/08/2020
53	DIS/1876/FDA/2020	Novalgine injection 50% (BN 180608 , EXP06/2021)	HebeiChengSheng Tang Animal Pharmaceuticals Co Ltd	—	Retail	Class II	Lack of storage condition on the labeling	Rwanda FDA inspection	31/08/2020
54	DIS/1876/FDA/2020	Complex Multivitamine injection veterinary medicine (BN: 190917, EXP: 09/2022)	HebeiChengSheng Tang Animal Pharmaceuticals Co Ltd	—	Retail	Class II	Lack of storage condition on the labeling	Rwanda FDA inspection	31/08/2020
55	DIS/1876/FDA/2020	Complex Multivitamine injection veterinary medicine (BN: 190813, EXP: 08/2022)	HebeiChengSheng Tang Animal Pharmaceuticals Co Ltd	—	Retail	Class II	Lack of storage condition on the labeling	Rwanda FDA inspection	31/08/2020
56	DIS/1941/FDA/2020	Purell-Instant Hand Sanitizer (60ML)	BELLA LTD	—	Retail	Class II	Failure to meet the quality of standard	Rwanda FDA	09/04/2020
57	DIS/1940/FDA/2020	Guard Hand Sanitizer 30ml Mfd:10/03/2020,10/03/2021	KVMS Co. Ltd,Tel: 250788851252	—	Retail	Class II	Failure to meet the quality of standard	Rwanda FDA	09/04/2020
58	Ref No137/RwandaFDA/2020	Entamizole DS ( Diloxanide furoate/ metronidazole 500/400mg)	ABBOTT LAB/PAKISTAN	—	Retail	Class II	batch number and expiry dates on blisters were different from the one on outer package	UNIPHARMA	19/03/2020
59	ODG/CRC/002/RwandaFDA/2020	Hand Sanitizers Manufactured by Oxalis Ltd	Oxalis Ltd	—	Retail	Class II	Failure to meet the quality of standard	Rwanda FDA inspection	15/03/2020
60	ODG/CRC/006/RwandaFDA/2020	BEU Hand Sanitizers	Holly Trust Ltd/Kamonyi District	—	Retail	Class II	Failure to meet the quality of standard	Rwanda FDA inspection	04/03/2020
61	Ref. No 260 / RwandaFDA/ 2020	Azithromycine dry powder suspension(Zerocin),BN:74261,Mfd:04/2019,Exp date:03/2021	Laboratory&Allied Ltd./kenya	—	Retail	Class II	Caking of the powder in the bottom of the bottles causing poor flowability	Found during investigation	13/02/2020
62	Ref. No 260 / RwandaFDA/ 2020	Azithromycine dry powder suspension(Zerocin),BN:74346,Mfd:05/2019,Exp date:04/2021	Laboratory&Allied Ltd./kenya	—	Retail	Class II	Caking of the powder in the bottom of the bottles causing poor flowability	Client using tweeter	13/02/2020
63	DIS/2129/FDA/2020	Lime Fresh Hand Sanitizer and disinfectants	Lime Fresh Family Ltd	—	Retail	Class II	The hand sanitiser do not contain Alcohol	Rwanda FDA	10/02/2020
64	DIS/1311/RwandaFDA/2020	Safe Hands Sanitizers-Instant Hand Sanitizer	KVM Co LTD	—	Retail	Class II	Poor quality Suspect	Rwanda FDA inspection	07/01/2020
65	Ref No.1539/Rwanda FDA/2019	Paracetamol suspension 120mg/5ml (Toto-moL®), B.N: 73718,mfg date: 02/2019, exp date: 01/2022	Laboratory&Allied Ltd./kenya	—	Retail	Class II	The product was detected with particulate matter	Client	20/11/2019
66	Ref No. 1722/RwandaFDA/2019	Urinalysis reagents strips with 3Parameters,BN:UR105111906A,Exp date:06/2021	Not mentioned	—	Retail	Class II	Manufacturing date,manufacturer's name and Manufacturer adress were not mentionned	District Pharmacies	12/09/2019
67	Ref No. 1722/RwandaFDA/2019	Urinalysis reagents strips with 3Parameters,BN:UR35111906A,Exp date:06/2021	Not mentioned	—	Retail	Class II	Manufacturing date,manufacturer's name and Manufacturer adress were not mentionned	District Pharmacies	12/09/2019
68	Ref No 0879/RwandaFDA/2019	Envit 100 ml,B.N:EEV 1713,Exp date:10/2019	Vitindia Pharmaceuticals Ltd A-6/1 India	—	Retail	Class II	The solution had issue of sedimentation		25/07/2019
69	Ref No 0879/RwandaFDA/2019	Envit 100 ml, B.N: EEV1808, Exp date: 07/2020	Vitindia Pharmaceuticals Ltd A-6/1 India	—	Retail	Class II	The solution had issue of sedimentation		25/07/2019
70	Ref No 0879/RwandaFDA/2019	Envit 100 ml, B.N: EEV1807, Exp date: 07/2020	Vitindia Pharmaceuticals Ltd A-6/1 India	—	Retail	Class II	The solution had issue of sedimentation		25/07/2019
71	Ref.No.0638/Rwanda FDA/2019	Chloramphenicol 0.5% w/v Eye Drops B.P; BN: 131936, Exp date: 01/2021	Abacus Parenteral Drugs Ltd., Uganda	—	Retail	Class II	Failed the Assay test (77.1%) and the degradation product content.	RBC/MPPD	18/06/2019
72	Ref.No.0638/Rwanda FDA/2019	Silver Sulfadiazine Cream USP 1% (Agoburn), BN: K82001, Exp date: 02/2021	Agog Pharma Ltd., India	—	Retail	Class II	Failed the Assay (82.2%) test in Lab Quality control tests	RBC/MPPD	18/06/2019
73	Ref.No.0638/Rwanda FDA/2019	Albendazole 400 mg Tablets BN: 370420, Exp date: 08/2022	GlaxoSmithKline South Africa (Pty) Ltd.	370420	Retail	Class II	The product failed to dissolution test in Lab Quality control tests	RBC/MPPD	18/06/2019
74	Ref No/0310/Rwanda FDA/2019	Dexamethasone 4mg/ml BN: 180468, Mfg date: 04/2018, Exp date: 03/2021	JIANGXI XIERKANGTAI PHARMACETICAL CO. LTD/CHINA	—	Retail	Class II	The route of administration was not mentioned	SUN Pharma/CHUB	14/03/2019
75	Ref No.0162/Rwanda FDA /2019	Hydralazine 20mg/ml BN: SX-18275; Mfg date: 07/2018,EXP: 06/2020	SWISS PARANTERALS Ltd	—	Retail	Class II	The manufacturer declared that they have failed to on-going stabilitity studies and urged the recall	PROLINE	21/02/2019
76	Ref No.0162/Rwanda FDA /2019	Hydralazine 20mg/ml BN: SX-18287 ,Mfg date: 07/2018; EXP: 06/2020	SWISS PARANTERALS ltd	—	Retail	Class II	the manufacturer declared that they have failed to on-going stabilitity studies and urged the recall	PROLINE	21/02/2019

Showing 76 of 124 recalls