Three of India’s top pharmaceutical companies—Sun Pharma, Lupin, and Dr. Reddy’s Laboratories—have initiated product recalls in the United States following manufacturing issues and product mix-ups, as per information released by the US Food and Drug Administration (USFDA).

Sun Pharmaceutical Industries has recalled 5,448 bottles of Lisdexamfetamine Dimesylate 60 mg capsules, used for treating attention-deficit hyperactivity disorder (ADHD). The recall was triggered due to failure in dissolution specifications, potentially impacting the drug’s effectiveness. The company commenced the voluntary Class II recall on June 16.

Lupin Pharmaceuticals has withdrawn 58,968 bottles of Lisinopril/Hydrochlorothiazide tablets (20 mg/12.5 mg) manufactured in its Nagpur facility. The batch was found to be contaminated with atazanavir/ritonavir tablets, prompting concerns over patient safety and compliance.

Dr. Reddy’s Laboratories issued a recall of 1,476 bottles of Omeprazole delayed-release capsules after they were found to contain Divalproex Sodium extended-release tablets, indicating a similar packaging or labelling mix-up. The recall was initiated on June 30.

All three actions have been classified as Class II recalls, which the USFDA defines as involving products that may cause temporary or medically reversible adverse health effects but are unlikely to cause serious health consequences.

These incidents once again highlight the critical importance of stringent quality control and compliance, especially for companies operating in highly regulated export markets like the United States.