April 15, 2021
Sun Pharmaceutical Industries Inc. is recalling 2520 bottles of metformin hydrochloride extended-release tablets for testing out-of-specification for water content, according to the April 14, 2021, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 500-count bottles of metformin hydrochloride extended-release tablets, 500 mg (NDC 62756-142-02), from lot JKU4639A (Exp. 10/22). The tablets were manufactured by Sun Pharmaceutical Industries Ltd., Gujarat, India, and distributed by Sun Pharmaceutical Industries, Cranbury, NJ, throughout the United States.
Sun Pharmaceutical Industries voluntarily initiated the recall March 25, 2021. On April 7, 2021, the FDA designated the recall Class III, suggesting use of the recalled product is not likely to cause harm.
Metformin is a prescription medication used to help control blood sugar levels in people with type 2 diabetes.