FDA Drugs recall ·
Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle… recall
- Recall number
- D-0525-2025
- Date
- (initiated June 30, 2025)
- Company / brand
- Dr. Reddy's Laboratories, Inc.
107 College Rd E, Princeton, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1476 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: C2403017, Exp 12/31/2026
Distribution
USA Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0525-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.