Drug Recall: 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 He
Dr. Reddy's Laboratories, Inc. · June 30, 2025
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
Distribution
USA Nationwide
States Affected
NATIONWIDE
Quantity Affected
1476 bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0525-2025
Status: ongoing
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