Superpotent Capsules Recalled

Superpotency concerns have prompted Sun Pharmaceutical Industries Inc to recall 2 lots of esomeprazole magnesium delayed-release capsules following out-of-specification assay results at the 12-month timepoint. The recall was included in the October 5, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were manufactured by Ohm Laboratories Inc, New Brunswick, NJ, and distributed by Sun Pharmaceutical Industries Inc, Cranbury, NJ, throughout the United States:

• esomeprazole magnesium delayed-release capsules, 20 mg, 90-count bottles (NDC 63304-734-90), from lot AC14299 (Exp. 12/22); and
• esomeprazole magnesium delayed-release capsules, 40 mg, 90-count bottles (NDC 63304-735-90), from lot AC14304 (Exp. 12/22).

Sun Pharmaceutical Industries voluntarily initiated the recalls, which have not yet been classified by the FDA, on June 21, 2022.

The recalled esomeprazole magnesium is a prescription proton pump inhibitor indicated for the treatment of erosive esophagitis, heartburn and other gastroesophageal reflux disease symptoms, gastric ulcer risk reduction, Helicobacter pylori eradication, and pathological hypersecretory conditions such as Zollinger-Ellison syndrome.