Rwanda Food and Drugs Authority
Public Product Recalls Register
QMS No: DIS/FMT/105
Revision No: 0
Effective Date: 07/10/2021
Ref. Doc.: DIS/GDL/034
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List of Recalled Products — AUGUST 2026

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

Total: 159 Class I: 39 Class II: 109 Class III: 11
SN File / Recall No. Medicine Name Manufacturer Batch No. Recall Level Class Quality/Safety Issue Date of Recall Details
1 Ref.No.:DD/PVCT/4261/FDA/2025
Povimax 10% (all volumes, all batches)
Scott Edil Pharmacia Limited, India
 ALL BATCHES Retail Class I
contains Alphox 200 (prohibited ingredient)
18/11/2025
2 Ref No 009/RMS/CEO/2025
Omiren (Omeprazole Capsules BP 20 mg) BN: 00124 exp. 3/2026
RENE INDUSTRIES LTD, Kampala/ Uganda
 BN: 00124 exp. 3/2026 Retail Class I
failed to comply with dissolution test specifications
03/01/2025
3 Ref.No.: DD/PVCT/1720/FDA/2024
Benylin Pediatrics Syrup BN:329304, Mfd: May 2021,Exp:April 2024
Johnson & Johnson, South Africa
 329304 Consumer Class I
Unacceptable high level of diethylene glycol
12/04/2024
4 Ref No.:FDISM/PVSM/4190/FDA/2023
Misoprostol tablet 200mcg BN: all, Exp: all
Angel Biogenics Private Ltd/ India
 All batches Retail Class I
Therapeutic ineffectiveness due to unacceptable lower level of active pharmaceutical ingredient (API) ( failed identification test and assay).
07/10/2023
5 Ref No.:FDISM/PVSM/3611/FDA/2022
Broncalene sp Enfants
MELISANA PHARMA
 BN: All Consumer Class I
Increased risk of anaphylactic reaction on curares products used during general anesthesia
16/09/2022
6 Ref.No.:FDISM/PVSM/3611/FDA/2022
Broncalene sp Adultes
MELISANA PHARMA
 BN: All Consumer Class I
Increased risk of anaphylactic reaction on curares products used during general anesthesia
16/09/2022
7 Ref No.: DIS/3261/FDA/2021
Losar-Denk 100 mg film Coated
DENK PHARMA
 ALL BATCHES Consumer Class I
Genotoxic impurity detected in API
07/10/2021
8 Ref No.: DIS/3261/FDA/2021
Losar-Denk 25 mg film Coated
DENK PHARMA
 ALL BATCHES Consumer Class I
Genotoxic impurity detected in API
07/10/2021
9 Ref No.: DIS/3261/FDA/2021
Losar-Denk 50 mg film Coated
DENK PHARMA
 ALL BATCHES Consumer Class I
Genotoxic impurity detected in API
07/10/2021
10 Ref No.: DIS/3261/FDA/2021
Colosar-Denk 50mg /12,5mg film coated tablet
DENK PHARMA
 ALL BATCHES Consumer Class I
Genotoxic impurity detected in API
07/10/2021
11 Ref No.: DIS/3261/FDA/2021
Colosar-Denk 100 mg /12,5mg film coated tablet
DENK PHARMA
 ALL BATCHES Consumer Class I
Genotoxic impurity detected in API
07/10/2021
12 DIS/1853/FDA/2021
Atropine injection,
Pharmax India Pvt.Ltd/India
 BN:16222001,Mfd:05/2020,Exp date:04/2023 Retail Class I
Presence of Particulate matters
25/05/2021
13 DIS/1853/FDA/2021
Furosemide injection 20mg/2ml,
Laborate Pharmaceuticals India
 BN:JFDIE-001,Mfd:11/2019,Exp:10/2022 Retail Class I
Presence of Particulate matters
25/05/2021
14 DIS/1853/FDA/2021
Hyoscine Butylbromide Injection BP 20mg/ml,
Centurion Healthcare Private Limited/601, Atlantis Heights, Sarabhai Compound, Vadi Wadi,Vadodara-390 007, Gujarat,INDIA
 BN:3H20001,Mfd:07/2020,Exp:06/2022 Retail Class I
Presence of Particulate matters in Vials and Piece of broken glass in the ampoule
25/05/2021
15 DIS/1853/FDA/2021
Phytomenadione Inj. BP 10mg/ml
SANJAR PHARMA LLP,Himatnagar-VijapurHighway,Dedhrota,Hitmatnagar-383 220, GUJARAT,INDIA
 BN:SA20C008E,Mfd:03/2020,Exp:02/2022 Retail Class I
Presence of Particulate matters in Vials
25/05/2021
16 Ref No137/RwandaFDA/2020
Debridat 4.8mg/ml granules for oral suspension,125ml
FARMEA10,RUE BOUCHE THOMASZAC SUD D'ORGEMONT 49000 Angers
 BN:3857,Exp.date:11/2020 Retail Class I
Potential foreign materials in the products
29/01/2020
17 Ref No137/RwandaFDA/2020
Debridat 4.8mg/ml granules for oral suspension,125ml
FARMEA10,RUE BOUCHE THOMASZAC SUD D'ORGEMONT 49000 Angers
 BN:3860,Exp.date:12/2020 Retail Class I
Potential foreign materials in the products
29/01/2020
18 Ref No137/RwandaFDA/2020
Debridat 4.8mg/ml granules for oral suspension,125ml
FARMEA10,RUE BOUCHE THOMASZAC SUD D'ORGEMONT 49000 Angers
 BN:3859,Exp.date:12/2020 Retail Class I
Potential foreign materials in the products
29/01/2020
19 Ref No137/RwandaFDA/2020
Debridat 4.8mg/ml granules for oral suspension,125ml
FARMEA10,RUE BOUCHE THOMASZAC SUD D'ORGEMONT 49000 Angers
 BN: 3858Exp.date:11/2020 Retail Class I
Potential foreign materials in the products
29/01/2020
20 Ref No137/RwandaFDA/2020
Debridat 4.8mg/ml granules for oral suspension,125ml
FARMEA10,RUE BOUCHE THOMASZAC SUD D'ORGEMONT 49000 Angers
 BN:3856,Exp.date:11/2020 Retail Class I
Potential foreign materials in the products
29/01/2020
21 Ref No137/RwandaFDA/2020
Debridat 24mg/ml granules for oral suspension,250ml
FARMEA10,RUE BOUCHE THOMASZAC SUD D'ORGEMONT 49000 Angers
 BN:3814,Exp.date:06/2020 Retail Class I
Potential foreign materials in the products
29/01/2020
22 Ref No137/RwandaFDA/2020
Debridat 24mg/ml granules for oral suspension,250ml
FARMEA10,RUE BOUCHE THOMASZAC SUD D'ORGEMONT 49000 Angers
 BN:3815,Exp.date:06/2020 Retail Class I
Potential foreign materials in the products
29/01/2020
23 Ref No137/RwandaFDA/2020
Debridat 24mg/ml granules for oral suspension,250ml
FARMEA10,RUE BOUCHE THOMASZAC SUD D'ORGEMONT 49000 Angers
 BN:3816,Exp.date:06/2020 Retail Class I
Potential foreign materials in the products
29/01/2020
24 Ref No137/RwandaFDA/2020
Debridat 24mg/ml granules for oral suspension,250ml
FARMEA10,RUE BOUCHE THOMASZAC SUD D'ORGEMONT 49000 Angers
 BN:3817,Exp.date:06/2020 Retail Class I
Potential foreign materials in the products
29/01/2020
25 Ref No137/RwandaFDA/2020
Debridat 24mg/ml granules for oral suspension,250ml
FARMEA10,RUE BOUCHE THOMASZAC SUD D'ORGEMONT 49000 Angers
 BN:3818,Exp.date:06/2020 Retail Class I
Potential foreign materials in the products
29/01/2020
26 Ref No137/RwandaFDA/2020
Debridat 24mg/ml granules for oral suspension,250ml
FARMEA10,RUE BOUCHE THOMASZAC SUD D'ORGEMONT 49000 Angers
 BN:3819,Exp.date:06/2020 Retail Class I
Potential foreign materials in the products
29/01/2020
27 Ref No137/RwandaFDA/2020
Debridat 24mg/ml granules for oral suspension,250ml
FARMEA10,RUE BOUCHE THOMASZAC SUD D'ORGEMONT 49000 Angers
 BN:3820,Exp.date:06/2020 Retail Class I
Potential foreign materials in the products
29/01/2020
28 Ref No137/RwandaFDA/2020
Debridat 24mg/ml granules for oral suspension,250ml
FARMEA10,RUE BOUCHE THOMASZAC SUD D'ORGEMONT 49000 Angers
 BN:3851,Exp.date:10/2020 Retail Class I
Potential foreign materials in the products
29/01/2020
29 Ref No137/RwandaFDA/2020
Debridat 24mg/ml granules for oral suspension,250ml
FARMEA10,RUE BOUCHE THOMASZAC SUD D'ORGEMONT 49000 Angers
 BN:3852,Exp.date:10/2020 Retail Class I
Potential foreign materials in the products
29/01/2020
30 Ref No137/RwandaFDA/2020
Debridat 24mg/ml granules for oral suspension,250ml
FARMEA10,RUE BOUCHE THOMASZAC SUD D'ORGEMONT 49000 Angers
 BN:3853,Exp.date:10/2020 Retail Class I
Potential foreign materials in the products
29/01/2020
31 Ref No137/RwandaFDA/2020
Debridat 24mg/ml granules for oral suspension,250ml
FARMEA10,RUE BOUCHE THOMASZAC SUD D'ORGEMONT 49000 Angers
 BN:3867,Exp.date:02/2021 Retail Class I
Potential foreign materials in the products
29/01/2020
32 Ref No 1756/ Rwanda FDA/2019
Helicobacter Pylori Antibody test strip,
QINGDAO HIGHTOP BIOTECH CO.,LTD/CHINA
 B.N HPB11303B, mfd date: HPB11303B, exp date: 03-2021 Retail Class I
The rapid test were giving false positive results
18/12/2019
33 ref No. 1756/Rwanda FDA/2019
Helicobacter Pyroli rapid tests,
QINGDAO HIGHTOP BIOTECH CO. LT
 BN: HPB11308, EXP :03/2020 Retail Class I
There were many false positif
18/12/2019
34 Ref No 1243/RwandaFDA/2019
Ranitidine ( all Brand ,all batches)
all
 all Brand ,all batches Retail Class I
contain nitrosamine impurity classified as probable human carcinogen
11/10/2019
35 Ref.No.0638/Rwanda FDA/2019
Biperiden.HCl Sterop Tablets 2 mg
Lab. STEROP NV, Belgium
 BN: 18B05  Exp date: 01/2023 Retail Class I
The medicine was found with higher rate of impurities in Laboratory quality control tests
18/06/2019
36 Ref. No 0108/ Rwandafda/2019
Cynomax (misoprostol 200ug) MAXTAR
BIO-GENICS /India
 B.N: M8TAB1801 (Exp: 4/2020) Retail Class I
Suspected poor Quality (Assay at 40%)
13/02/2019
37 Ref. No 0108/ Rwandafda/2019
C-STOL (Misoprostol 200 ug) CORONA
Remedies Pvt Ltd/India
 B.N: ERW-005, EXP: 2/2021 Retail Class I
Suspected poor Quality (Assay at 40%)
13/02/2019
38
ANIOS SPECIAL DJP SF 4X5L, B.N:B14316S
Laboratoires Anios
— Retail Class I
The product was reported to be contaminated by a bacteria
—
39
ANIOS SPECIAL DJP SF 4X5L, B.N:A24104S
Laboratoires Anios
— Retail Class I
The product was reported to be contaminated by a bacteria
—
Showing 39 of 159 recalls