Subpotent Drug Recalled

Bausch Health Companies Inc. is recalling 3600 cartons of omeprazole and sodium bicarbonate powder for oral suspension distributed by Oceanside Pharmaceuticals. According to the March 6, 2024, US Food and Drug Administration (FDA) Enforcement Report, testing revealed the product may be subpotent.

The recall affects omeprazole and sodium bicarbonate powder for oral suspension, 40 mg/1680 mg (NDC 68682-991-30), from lot 0013R (Exp. 1/26). Oceanside Pharmaceuticals, a division of Bausch Health US, Bridgewater, New Jersey, distributed the product throughout the United States. 

Bausch Health Companies voluntarily initiated the recall February 2, 2024. On February 28, 2024, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Omeprazole and sodium bicarbonate powder is a prescription medication with indications for upper gastrointestinal bleeding in critically ill adults, as well as active duodenal ulcer, active benign gastric ulcer, and gastroesophageal reflux disease symptoms.