OTC Acid Reducer Recalled

A single lot of over-the-counter lansoprazole delayed-release capsules are being recalled because of deviations from Current Good Manufacturing Practice regulations, according to the April 17, 2024, US Food and Drug Administration (FDA) Enforcement Report. No details on the specific deviations were provided.

The recall affects 30 bottles of lansoprazole delayed-release capsules, 15 mg, 14-capsule bottles (NDC 16571-742-41), from lot 411988 (Exp. 5/31/25). The product was manufactured by Natco Pharma Limited, Kothur, India, and distributed by Rising Pharma Holdings Inc., East Brunswick, New Jersey, throughout the United States.

Natco Pharma Limited voluntarily initiated the recall March 27, 2024. On April 5, 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.

Lansoprazole is a proton-pump inhibitor used to treat frequent heartburn.