Class IIOngoing

Omeprazole Delayed-release Capsules recall

FDA recall D-0525-2025 · initiated Jun 30, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.

Details

Product: Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10
Recalling company: Dr. Reddy's Laboratories Limited
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: USA Nationwide
Initiated: Jun 30, 2025
FDA report date: Jul 23, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0525-2025 ↗

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