DRAP Recalls Two Popular Antibiotics Over Safety Risks

The Drug Regulatory Authority of Pakistan (DRAP) has issued a voluntary recall alert for two widely used antibiotic suspensions manufactured by GlaxoSmithKline Pakistan Ltd (GSK), citing faulty induction seals that may pose safety risks.

Affected Products and Batches

According to DRAP’s Medical Product Alert No. II/V/08-25-53, the recall affects:

1. Amoxil Forte Suspension 250mg (Reg. #000814)

   • Total affected batches: 58

   • Issue: Defective cap and induction sealing

2. Amoxil Suspension 125mg (Reg. #000508)

   • Total affected batches: 111

   • Issue: Same induction seal and capping flaws

The defective seals could potentially compromise product sterility, leading to contamination or reduced efficacy.

GSK Pakistan, located at F-268, S.I.T.E. Karachi, voluntarily informed DRAP of the issue. The authority subsequently directed that all affected batches be removed from the market immediately.

Hospitals, pharmacies, and distributors across Pakistan have been instructed to identify and return the recalled batches to avoid potential health risks. DRAP has urged healthcare professionals and regulatory field forces to take swift action to ensure public safety.

The recalled batch numbers are listed in full in the DRAP alert issued on August 5, 2025, and are available on the official DRAP website.

Healthcare providers and the general public are advised to avoid using any affected batch of Amoxil 125mg or 250mg suspensions. Anyone in possession of the listed products should return them to their nearest pharmacy or report to DRAP via its complaint portal.