Omeprazole Capsules Recalled Due to Contamination With Foreign Divalproex Tablet

Dr. Reddy’s Laboratories Inc has voluntarily initiated a Class II recall of Omeprazole Delayed-Release Capsules, USP, 20mg, packaged in 1000-count bottles under NDC 82009-022-10. This product, manufactured in India by Dr. Reddy's Laboratories Limited and distributed under the label of Qualient Pharmaceuticals Health LLC (Grand Cayman), is being recalled due to the confirmed presence of a foreign tablet, Divalproex Sodium Extended-Release 250 mg, within a bottle of omeprazole capsules. The affected lot is C2403017 with an expiration date of December 31, 2026, and 1476 bottles are impacted.

The recall was classified as Class II by the US Food and Drug Administration (FDA) on July 14, 2025, indicating that exposure to the product may cause temporary or medically reversible adverse health consequences, but the probability of serious adverse health effects is remote. The firm initiated the recall on June 30, 2025, via letters to its consignees, and the status remains ongoing. The distribution was nationwide across the US, though no public press release has been issued to date.

Omeprazole is a widely prescribed proton pump inhibitor used to treat conditions such as gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, and other disorders involving excessive stomach acid. Contamination with divalproex sodium—typically used to treat seizure disorders, bipolar disorder, and migraines—poses potential safety risks due to the drug’s completely unrelated pharmacologic profile, especially in vulnerable populations such as pediatric or elderly patients. Pharmacists are urged to review inventory and cease distribution of the affected lot immediately.