India Pharma Outlook Team | Monday, 28 July 2025
As part of a trend that is causing concern in the industry regarding the quality of drugs and adherence to across-the-board manufacturing standards, major Indian drugmakers such as Sun Pharma, Lupin and Dr Reddy Laboratories have initiated voluntary recalls of lots of drugs in the US market as reported in the recent Enforcement Report of the US Food and Drug Administration (USFDA).
Sun Pharmaceutical Industries, based in Mumbai, is recalling 5,448 bottles of Lisdexamfetamine Dimesylate capsules (60 mg), a drug prescribed for attention deficit hyperactivity disorder (ADHD). The recall, initiated on June 16 by its Princeton-based subsidiary, was triggered due to “Failed Dissolution Specifications,” according to the USFDA.
Lupin Pharmaceuticals Inc., the US unit of the Mumbai based Lupin has recalled 58,968 bottles of Lisinopril and Hydrochlorothiazide Tablets (USP 20mg/12.5mg), which are used to treat hypertension patients. The recall, initiated on June 20, is due to “Product Mix Up.” The USFDA report noted: “This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.”
Also Read: India-UK Trade Pact's IP Terms Spark Concerns in Pharma Sector
Similarly, the Dr Reddy's Laboratories have recalled 1,476 bottles of Omeprazole Delayed-Release Capsule within the US market. This recall was started on June 30, as a result of identification of foreign Divalproex Sodium extended-release 250mg tablets in omeprazole bottles.
The USFDA classifies all three as Class II recalls, indicating the potential for temporary or medically reversible health effects.
