Proton Pump Inhibitor Recalled

Two lots of lansoprazole tablets are being recalled Dr Reddy’s Laboratories Inc after samples failed to meet dissolution specifications during testing, according to the August 3, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were made in India and distributed throughout the United States by Dr Reddy’s Laboratories, Princeton, NJ:

• lansoprazole delayed-release orally disintegrating tablets, 15 mg, 100-count blisters per carton, 10 packs of 10 tablets each (blister barcode 4359856079, NDC 43598-560-78), from lot T2100514 (Exp. 1/23); and
• lansoprazole delayed-release orally disintegrating tablets, 35 mg, 100-count blisters per carton, 10 packs of 10 tablets each (blister barcode 4359856179, NDC 43598-561-78), from lot T2100515 (Exp. 1/23).

Dr Reddy’s Laboratories voluntarily initiated the recall July 13, 2022. On July 22, 2022, the FDA designated the recall Class II, communicating use of the tablets may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Lansoprazole is a prescription proton pump inhibitor used in the treatment of duodenal ulcers, gastric ulcers, gastroesophageal reflux disease, erosive esophagitis, and pathological hypersecretory conditions, including Zollinger-Ellison syndrome.