Proton Pump Inhibitor Recalled

Glenmark Pharmaceuticals Inc. USA is recalling 30- and 100-count bottles of esomeprazole magnesium delayed-release capsules. According to the November 29, 2023, US Food and Drug Administration (FDA) Enforcement Report, 18-month testing of the product showed out-of-specification results for organic impurities.

The recall affects esomeprazole magnesium delayed-release capsules, 20 mg, in 30-count (NDC 68462-390-30) and 1000-count (NDC 68462-390-10) bottles from 17220002 (Exp. 11/30/23). The capsules were manufactured in India for Glenmark Pharmaceuticals, Mahwah, New Jersey, and were distributed throughout the US.

Glenmark Pharmaceuticals voluntarily initiated the recall October 23, 2023. On November 20, 2023, the FDA designated the recall Class III. Per the classification, use of the capsules is not likely to cause harm.

Esomeprazole magnesium is a prescription drug with indications that include erosive esophagitis, gastroesophageal reflux disease, and pathological hypersecretory conditions, as well as risk reduction of gastric and duodenal ulcers.