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
Reported: July 23, 2025 Initiated: June 30, 2025 #D-0525-2025
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
Reason for Recall
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 1476 bottles
- Distribution
- USA Nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 1476 bottles.
Why was this product recalled? ▼
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 23, 2025. Severity: Moderate. Recall number: D-0525-2025.
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