Recalling firm
Dr. Reddy's Laboratories, Inc.
Product type
Drug
Status
Ongoing
Report date
2025-07-23
Distribution
USA Nationwide
Firm state
NJ
Product quantity
1476 bottles
Initiated by
Voluntary: Firm initiated
Reason for recall
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Product description
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
Code / lot info
Lot: C2403017, Exp 12/31/2026
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.