Opioid Analgesic Recalled

Dr Reddy’s Laboratories Inc. is recalling 2040 bottles of morphine sulfate extended-release tablets for failing to meet impurity/degradation specifications, according to the November 13, 2024, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects morphine sulfate extended-release tablets, 15 mg, in 100-count bottles (NDC 51862-185-01), from lot FG14062 (Exp. 10/31/25). The tablets were manufactured by Mayne Pharma, Greenville, North Carolina, and were distributed throughout the United States.

Dr Reddy’s Laboratories voluntarily initiated the recall October 22, 2024. On November 4, 2024, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm, if used.

Morphine sulfate extended-release tablets are a Schedule II controlled substance indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment when alternative treatments are inadequate.