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Class II · ModerateRecall completed

Acid Reducer

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

Does this affect you?
Check your lot numberBT001594C
Where it was soldNationwide in the USA
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

CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.

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 byLEADER/ Cardinal Health 110, Inc.
Brand nameACID REDUCER
Generic nameOMEPRAZOLE MAGNESIUM
Active ingredient(s)OMEPRAZOLE MAGNESIUM
Distributed by / forCardinal Health, Dublin, OH 43017
NDC70000-0232-1
Show the full FDA record
Full product labelOmeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC 70000-0232-1
Recalling firmDr. Reddy's Laboratories, Inc.
DistributionNationwide in the USA
Quantity8,976 bottles
Recall initiated2021-10-05
Report date2021-10-27
Recall completed2022-12-06
Recall numberD-0026-2022
ClassificationClass II
FDA statusTerminated
Origin on filePrinceton NJ United States

Related

Recent 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.