Dr Reddy’s, Zydus Lifesciences recall medicines from US market over quality issues

Dr Reddy’s Laboratories and Zydus Lifesciences are recalling certain medicines from the US after USFDA found manufacturing and quality issues. The recalls, affecting muscle relaxant and hepatitis B drugs, are precautionary and classified as moderate-risk (Class II)

New Delhi: Two major Indian pharmaceutical companies, Dr Reddy’s Laboratories and Zydus Lifesciences, are recalling certain medicines from the US market due to manufacturing issues, the US health regulator has said.

According to the latest enforcement report by the US Food and Drug Administration (USFDA), an American subsidiary of Hyderabad-based Dr Reddy’s is recalling 571 vials of Succinylcholine Chloride Injection, a medicine used to relax muscles. The recall was initiated on September 26 after the USFDA reported an “out-of-specification result during six-month stability testing.”

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The affected batch is being withdrawn nationwide in the United States as a Class II recall, which indicates that exposure to the product may cause temporary or reversible health problems, but serious health issues are unlikely.

Similarly, the US arm of Zydus Lifesciences, Zydus Pharmaceuticals (USA) Inc, is recalling over 1,500 boxes of Entecavir tablets, an antiviral medicine used mainly to treat chronic hepatitis B.

The recall, which began on September 24, involves 912 bottles of 0.5 mg tablets and 600 bottles of 1 mg tablets. The USFDA cited “failed impurity/degradation specifications” as the reason for the recall.

India is home to the largest number of USFDA-compliant pharmaceutical plants outside the United States, and such recalls highlight the strict regulatory oversight maintained by the US authorities. This is not the first instance of Indian drug makers recalling medicines from the US market.

Earlier, companies like Sun Pharma, Lupin, and Dr Reddy’s had initiated similar recalls over product mix-ups and quality issues, ensuring patient safety remains a priority.

In July this year, Sun Pharmaceutical Industries, headquartered in Mumbai, recalled 5,448 bottles of a generic drug used to treat Attention Deficit Hyperactivity Disorder (ADHD). The medicine in question was Lisdexamfetamine Dimesylate capsules, which failed to meet the required dissolution standards during testing.