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Class II · ModerateRecall completed

Omeprazole Delayed-Release Capsules

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

Does this affect you?
Check your lot numberLot # 191659, exp. date 05/2021
Where it was soldProduct was distributed 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

Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.

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 byTow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain foreign manufacturer
Distributed by / forBreckenridge Pharmaceutical, Inc., Berlin, CT
NDC51991-643-10
Show the full FDA record
Full product labelOmeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10
Recalling firmBreckenridge Pharmaceutical, Inc
DistributionProduct was distributed nationwide
Quantity3,146 bottles
Recall initiated2021-03-11
Report date2021-03-24
Recall completed2022-03-23
Recall numberD-0308-2021
ClassificationClass II
FDA statusTerminated
Origin on fileBerlin CT United States

Related

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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.