Islamabad, August 5, 2025: The Drug Regulatory Authority of Pakistan (DRAP), through its Quality Control Directorate, has issued a directive to immediately recall multiple batches of GlaxoSmithKline (GSK) Pakistan’s Amoxil Forte syrup from the market due to packaging and sealing defects.
According to an official DRAP notification, the decision was made following a formal communication from GSK Pakistan, which reported cap and seal deficiencies in two variants of the widely used antibiotic syrup: Amoxil Forte 250mg/5ml and Amoxil Forte 125mg/5ml. As a result, DRAP has instructed the company to withdraw 58 batches of Amoxil Forte 250mg and 111 batches of Amoxil Forte 125mg from the market immediately.
The DRAP letter highlights that these packaging faults could potentially pose health risks to consumers and therefore require urgent corrective action. Hospitals, pharmacies, and relevant institutions across the country have been directed to identify and return the affected stock without delay.
Affected batches
Amoxil Forte 250mg/5ml – 58 batches
These include, but are not limited to, 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 Forte 125mg/5ml – 111 batches
Key affected batches include 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, and several others.
DRAP has urged all relevant health institutions, distributors, and pharmacies to immediately identify and return the listed batches to prevent any potential health risks to the public. The directive emphasizes the importance of stringent quality control in pharmaceutical packaging, especially for pediatric medications such as Amoxil Forte, which is commonly prescribed for bacterial infections.
