FDA Issues Recall for Morphine Sulfate Extended-Release Tablets

A Class II recall has been initiated for Morphine Sulfate Extended-Release Tablets, 100 mg, manufactured by Ohm Laboratories Inc. and distributed by Sun Pharmaceutical Industries, Inc. The recall affects 9840 bottles, each containing 100 tablets, distributed nationwide. 

The affected product comes from Lot #AD16615, with an expiration date of July 2025. The recall was prompted by failed dissolution specifications, which could lead to improper drug release and potential under-dosing or overdose risks. The recall was voluntarily initiated on February 6, 2025, and remains ongoing.

The recalling firm, Sun Pharmaceutical Industries Inc., based in Princeton, New Jersey, has notified its consignees via letter. The US Federal Drug Administration (FDA) classified the recall as Class II, meaning the product may cause temporary or medically reversible adverse health effects, but serious health consequences are unlikely. 

Morphine sulfate extended-release is an opioid analgesic used for the management of severe pain requiring around-the-clock, long-term opioid treatment. Improper dissolution can lead to inconsistent pain relief, withdrawal symptoms, or increased risk of overdose.