Recall
FDAHealthJune 30, 2025

Dr. Reddy's Laboratories, Inc. — Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
June 30, 2025

USA Nationwide

What's affected?

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
Lot code
C2403017

Additional details

Lot: C2403017, Exp 12/31/2026

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 1476 bottles.

View original FDA notice →

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