DRAP RECALL ALERT OF “AMOXIL SUSPENSION AND AMOXIL FORTE SUSPENSION” due to complaint of Induction Seal.
DRAP Alert No: II/V/08-25-53
Date of Action: 5th August 2025
Intended Audience:
National Regulatory Field Force
Pharmacists and chemists in distribution, pharmacies, and medical stores
Healthcare professionals – physicians, pharmacists, and nurses in hospitals and clinics
General public
Issue Summary:
M/s GlaxoSmithKline Pakistan Ltd., F-268, S.I.T.E., Karachi (DML No. 000233) has notified the Drug Regulatory Authority of Pakistan (DRAP) about a voluntary recall of the following drug products due to a defective induction seal.
Products Affected:
Amoxil Forte Suspension 250 mg
Registration No.: 006814
Manufacturer: M/s GlaxoSmithKline Pakistan Ltd., F-268 S.I.T.E., Karachi (DML No. 000233)
Affected Batch Numbers: 7W9V, 7W9W, 7W9X, 8L5H, 8R3M, 8L5J, 8R4J, 8R4G, 8R3N, 8R4M, 8R4N, 8T5A, 9S5D, 9S5B, 9U6F, 9X3E, 9U6E, 9X3G, 9X3F, AH9Y, AJ2A, AP2M, AP2N, AP2P, AP2T, AS5B, AS5K, AS5F, AT7M, AS5L, C25W, C25X, C37E, C37G, C99F, C58B, CB4N, CB4P, CB4R, CD6T, CD6W, CD6V, DL5L, DL5K, DL5M, EE9R, EE9N, DY5U, EE9T, EG2A, FA8M, FA8N, FB9C, FB9D, FB9E, FB9F, FE9X, FF2A.Amoxil Suspension 125 mg
Registration No.: 000508
Manufacturer: M/s GlaxoSmithKline Pakistan Ltd., F-268 S.I.T.E., Karachi (DML No. 000233)
Affected Batch Numbers: 8U3B, 8T5G, 8T5L, 8U3A, 8U3G, 8U3H, 8W9S, 8W9T, 925W, 925Y, 926B, 926A, 956M, 956R, 966V, 967C, 967F, 967E, 988F, 988H, 988G, 9B4P, 988K, 9B4M, 9B4S, 9D6K, 9B4T, 9D6M, 9D6P, 9D6T, 9G4N, 9G4P, 9L9N, 9L9M, 9P7R, 9P7S, 9R2V, 9R2U, 9S4Y, 9S5A, AW3A, AW3B, AW3H, AW3D, AY5T, AY5X, AY5V, AY6B, B44T, B44M, B44S, BB2Y, B44V, BB3A, BB3B, BF3B, BF2X, BB3C, BF3C, BF3A, BT9H, BT9G, BT9F, BT9J, BW8R, BW8M, BW8S, BW8T, BX8L, BX8N, BX8P, CG4V, CG4X, CG4W, CG4Y, CJ7B, CJ6W, CJ7C, CJ7D, CP5G, CP5H, CT5X, CT6A, CW3H, CW3G, CY3A, D64P, D64S, CY3K, EP7E, EN4U, EN4T, EP7J, EP7M, EP7P, ET8M, EW3F, F55S, F32W, F55V, F55U, F55T, F97P, F75G, F75J, F75K, F75N, FT2Y, FU7X, FU7Y, FT3A.
Reason for Recall:
These products are being recalled due to a defective induction seal on bottles, which may compromise product integrity. The defect might go unnoticed and could pose a risk under certain storage or usage conditions. The recall is a precautionary measure to protect public health, initiated in consultation with DRAP.
Actions Taken:
DRAP’s regulatory field force and provincial drug control authorities have been directed to conduct market inspections and remove the affected batches from circulation.
Pharmacists, chemists, and distributors must immediately check their inventory, stop supplying the affected batches, quarantine remaining stock, and inform their area drug inspector for collection.
Distributors and pharmacies should remain vigilant and report any suspected batch via DRAP’s online reporting form or by email at gsms@dra.gov.pk.
Surveillance in all provinces and regions has been intensified to ensure effective recall.
Advice for Healthcare Professionals:
Increase vigilance within your institution’s supply chain to detect and remove affected batches.
Report any adverse reactions or quality issues to the National Pharmacovigilance Centre (NPC), DRAP, via the Adverse Event Reporting Form or the online portal.
Further guidance on reporting is available on DRAP’s official website.
Advice for Consumers:
Stop using any product from the affected batch numbers immediately.
Consult your physician or healthcare provider if you experience any problem that may be related to these products.
Purchase medicines only from licensed and authorized pharmacies/outlets. Always check product authenticity and packaging integrity before use. If in doubt, seek advice from your pharmacist.
Reference:
Drug Regulatory Authority of Pakistan. (2025, August 5). Voluntary recall alert – Amoxil Forte Suspension & Amoxil Suspension due to complaint of induction seal. https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/voluntary-recall-alert-amoxil-forte-suspension-amoxil-suspension-due-to-complaint-of-induction-seal/
