Proton Pump Inhibitors Recalled

Dr Reddy’s Laboratories Inc is recalling 3 lots of lansoprazole delayed-release capsules because samples failed to meet dissolution specifications during long-term stability testing, according to the April 6, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall includes the following lansoprazole products, which were manufactured by Dr Reddy’s Laboratories Limited, Bachupally, India, and distributed throughout the United States:

• lansoprazole delayed-release capsules, 15 mg, 30-count bottle (NDC 55111-398-30), from lot C2103093 (Exp. 12/23);
• lansoprazole delayed-release capsules, 15 mg, 90-count bottle (NDC 55111-398-90), from lot C2103092 (Exp. 12/23); and
• lansoprazole delayed-release capsules, 30 mg, 90-count bottle (NDC 55111-399-90), from lot C2102911 (Exp. 12/23).

Dr Reddy’s Laboratories voluntarily initiated the recall March 23, 2022. The FDA designated the recall Class II on March 31, 2022, signaling use of the affected medication could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

The recalled lansoprazole delayed-release capsules are prescription proton pump inhibitors used to treat certain stomach and esophagus problems, such as acid reflux and ulcers.