DRAP Issues Nationwide Recall of Popular GSK Antibiotic Suspensions Over Safety Concerns
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). The recall follows the discovery of defective induction seals, which may pose serious safety risks to consumers.
🚨 Products Affected by the Recall
According to DRAP Medical Product Alert No. II/V/08-25-53, the following products are involved:
✅ Amoxil Forte Suspension 250mg
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Registration No: 000814
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Total Batches Affected: 58
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Issue: Faulty induction seal and defective cap
✅ Amoxil Suspension 125mg
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Registration No: 000508
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Total Batches Affected: 111
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Issue: Same induction seal and capping defects
These faulty seals could potentially compromise the sterility of the product, raising concerns about contamination or reduced effectiveness, particularly dangerous in pediatric and vulnerable populations.
🏭 GSK’s Response and DRAP’s Action
GSK Pakistan, located at F-268, S.I.T.E. Karachi, voluntarily alerted DRAP after identifying the sealing issue internally. In response, DRAP has directed that all affected batches be pulled from pharmacies, hospitals, and distributors across the country with immediate effect.
The full list of affected batch numbers is available on the official DRAP website, listed under the August 5, 2025 recall notice.
🛡️ What Consumers and Healthcare Providers Should Do
DRAP has urged all healthcare professionals, pharmacists, and regulatory field officers to take swift and proactive measures to:
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Remove affected products from circulation
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Prevent the sale or use of compromised antibiotic suspensions
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Educate patients on identifying and returning the affected batches
Consumers are strongly advised not to use any batch of Amoxil 125mg or 250mg suspensions listed in the recall. If you have these medicines at home:
✅ Stop using them immediately
✅ Return them to the pharmacy
✅ Or report via the DRAP complaint portal
🩺 Your Health and Safety Comes First
This recall is a critical reminder to always check medication batch numbers and stay updated with alerts from regulatory authorities like DRAP. Ensuring medicine safety is a shared responsibility — between manufacturers, authorities, healthcare providers, and the public.
Stay informed, stay safe.
