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FDAFDA · Food and drugs·Recall number D-0525-2025

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

Published July 23, 2025 · Recall initiated: June 30, 2025

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
OMEPRAZOLE
Manufacturer
Dr. Reddy's Laboratories, Inc.
Distributor
USA Nationwide
Lot
Lot: C2403017, Exp 12/31/2026
Risk classification
Class II
Area (FDA)
drug
Country
United States

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