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Class II · ModerateActive recall

Omeprazole

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot: C2403017, Exp 12/31/2026
Where it was soldUSA Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byDr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands foreign manufacturer
Brand nameOMEPRAZOLE
Generic nameOMEPRAZOLE
Active ingredient(s)OMEPRAZOLE
Distributed by / forQualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands
NDC82009-022-10
Show the full FDA record
Full product labelOmeprazole 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
Recalling firmDr. Reddy's Laboratories, Inc.
DistributionUSA Nationwide
Quantity1476 bottles
Recall initiated2025-06-30
Report date2025-07-23
Recall completed—
Recall numberD-0525-2025
ClassificationClass II
FDA statusOngoing
Origin on filePrinceton NJ United States

Related

Omeprazole recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.