Medicine Quality Alert: Class II Medicine Recall of Ibuflam plus Suspension 60ml (Paracetamol 125mg, Ibuprofen 100mg per 5ml) Batch No. 0424097 and 0824011
Biodeal Laboratories Limited has initiated an urgent voluntary recall of Ibuflam plus Suspension 60ml (Paracetamol 125mg, Ibuprofen 100mg per 5ml), Batch No. 0424097 and 0824011
From: Pharmacy and Poisons Board
Date of Recall Initiation: 7th November 2025
Recall Reference Number: REC/2025/034
Recall Classification: Class II
Recall Level: Retail/Facility level
Manufacturer: Biodeal Laboratories Limited, Kenya
Product name: Ibuflam Plus Suspension 60ml
Active Pharmaceutical Ingredient: Paracetamol 125mg, Ibuprofen 100mg per 5ml
Affected counties: All
Affected Batch
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
0424097 | 04/2024 | 03/2027 | 60ml |
0824011
| 08/2024 | 07/2027 | 60ml |
Brief description of the problem
Biodeal Laboratories Limited, Kenya, initiated a voluntary recall due to the product’s failure to meet the specification for PH and the low contents of paracetamol.
Action for healthcare professionals
Quarantine all remaining stock and stop further distribution, sale, issuing, or use of the above batch immediately. Await contact from Biodeal Laboratories Limited, Kenya, to arrange the return.
Action for patients and caregivers
No further action is required by patients, as this is a Retail/hospital Pharmacy and Wholesaler/Distributor level recall. You are advised to talk to your healthcare professional if you have the above batch of Ibuflam Plus Suspension 60ml. The patients should continue taking other batches of the product, other than the impacted batch, and as prescribed by the healthcare professional.
Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via pv@pharmacyboardkenya.org; regulatory@pharmacyboardkenya.org
Further Information
For medical information inquiries, please contact Biodeal Laboratories Ltd, Kenya,at:regulatoryaffairs@biodealkenya.com , , chriskibathi@biodealkenya.com, freshia@biodealkenya.com or via telephone: +254 722 214178
Promptly report any cases of adverse events and suspected substandard and falsified products to the nearest healthcare facility or through the following channels:
- https://pv.pharmacyboardkenya.org/users/mpublic
- USSD code at *271#
- Email pv@ppb.go.ke or pms@ppb.go.ke
- Telephone No. 0795743049
- Mobile application: mPvERS both Android and iOS
For any further enquiries and feedback on the product recall, contact the post-marketing surveillance unit at the Pharmacy and Poisons Board via email at pms@ppb.go.ke
Download report
Medicine Quality Alert: Class II Medicine Recall of Ibuflam plus Suspension 60ml (Paracetamol 125mg, Ibuprofen 100mg per 5ml) Batch No. 0424097 and 0824011