Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot: C2403017, Exp 12/31/2026
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0525-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 30, 2025
- FDA report date
- Jul 23, 2025
- Quantity
- 1476 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0525-2025, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97161
- Address
- 107 College Rd E
- Code information
- Lot: C2403017, Exp 12/31/2026
- Postal code
- 08540-6623
- Report date
- Jul 23, 2025
- Product type
- Drugs
- Recall number
- D-0525-2025
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 1476 bottles
- Reason for recall
- Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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 pattern
- USA Nationwide
- Recall initiation date
- Jun 30, 2025
- Initial firm notification
- Letter
- Center classification date
- Jul 14, 2025