Omeprazole Capsules Recalled Due to Foreign Tablet Contamination

The US Food and Drug Administration (FDA) has issued a Class II recall for Omeprazole Delayed-Release Capsules, USP, 20 mg (1000-count bottles) after a foreign tablet of Divalproex Sodium Extended-Release 250 mg was discovered in a bottle of Omeprazole. The affected product—Lot C2403017, Exp. 12/31/2026—was manufactured by Dr. Reddy’s Laboratories Limited in India and labeled for Qualient Pharmaceuticals Health LLC, Grand Cayman. A total of 1476 bottles were distributed nationwide, and the voluntary recall was initiated on June 30, 2025.

The recalling firm, Dr. Reddy’s Laboratories, Inc., based in Princeton, New Jersey, notified customers via letter. The recall was classified as Class II by the FDA on July 14, 2025, indicating that use of the product may cause temporary or medically reversible adverse effects, with a low likelihood of serious injury. The presence of an unintended Divalproex Sodium tablet poses a significant risk of medication errors, adverse drug reactions, and unintentional exposure, particularly in vulnerable populations such as those taking multiple medications or with contraindications to Divalproex.

Omeprazole is a proton pump inhibitor (PPI) used to treat conditions such as gastroesophageal reflux disease (GERD), gastric ulcers, and Zollinger-Ellison syndrome by reducing stomach acid production.