Drug recall D-0525-2025

Class II Ongoing reported Jul 23, 2025

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

Reason for recall

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

Lots and codes

Lot: C2403017, Exp 12/31/2026

Recall details

Recalling firm
Dr. Reddy's Laboratories, Inc., Princeton, NJ
Quantity
1476 bottles
Distribution
USA Nationwide
Type
Voluntary: Firm initiated
Recall initiated
June 30, 2025

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