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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 #: GS029673, Exp. Date 5/2021
Where it was soldSold to two wholesalers/distributors under government contract located in PA and TX
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 by manufacturer

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

Distributed by / forGolden State Medical Supply Inc.
NDC51407-129-10
Show the full FDA record
Full product labelOmeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo, CA 93012-8601 USA, NDC 51407-129-10
Recalling firmGolden State Medical Supply Inc.
DistributionSold to two wholesalers/distributors under government contract located in PA and TX
QuantityN/A
Recall initiated2021-03-19
Report date2021-03-31
Recall completed2021-07-28
Recall numberD-0312-2021
ClassificationClass II
FDA statusTerminated
Origin on fileCamarillo CA 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.