D-0525-2025 Class II Ongoing
FDA drug recall D-0525-2025 was initiated by Dr. Reddy's Laboratories, Inc. on June 30, 2025 and is designated Class II. Reason for recall: Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules. The recall status is ongoing. Affected quantity: 1476 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 23, 2025
- Initiation Date
- June 30, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1476 bottles
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.
Distribution Pattern
USA Nationwide
Code Information
Lot: C2403017, Exp 12/31/2026