Omeprazole (Prilosec) recalls

Omeprazole is a proton pump inhibitor used for acid reflux and heartburn. We track every FDA enforcement recall involving Omeprazole (Prilosec) — 17 recalls in our database, including 4 active.

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Recent Omeprazole recalls

Class IIActiveJun 30, 2025
Dr. Reddy's Laboratories, Inc. — Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Recall D-0525-2025
Class IIActiveMay 13, 2025
Zydus Pharmaceuticals (USA) Inc — Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Recall D-0442-2025
Class IIActiveMay 13, 2025
Zydus Pharmaceuticals (USA) Inc — Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Recall D-0443-2025
Class IIIActiveNov 14, 2024
Zydus Pharmaceuticals (USA) Inc — Labeling: Not Elsewhere Classified - Wrong NDC number
Recall D-0102-2025
Class IIFeb 2, 2024
Bausch Health Companies, Inc. — Subpotent Drug: Out of specification for assay
Recall D-0355-2024
Class IIIOct 23, 2023
Glenmark Pharmaceuticals Inc., USA — Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).
Recall D-0112-2024
Class IIIJun 21, 2022
SUN PHARMACEUTICAL INDUSTRIES INC — Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Recall D-0004-2023
Class IIIJun 21, 2022
SUN PHARMACEUTICAL INDUSTRIES INC — Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Recall D-0005-2023

Showing 8 of 17. See all Omeprazole recalls.

What to do if your Omeprazole is recalled

Don’t panic — and don’t stop taking it on your own. Suddenly stopping a prescription can be riskier than the recall itself.
Check the details. Recalls often affect specific lots, manufacturers, or strengths — not every bottle of Omeprazole.
Talk to your pharmacist or doctor about whether your supply is affected and what to do next.

This page is for information only and isn’t medical advice. Always follow your clinician’s guidance.

Omeprazole recall FAQs

How will I know if my Omeprazole is recalled?

The FDA publishes recalls, but most never make the news. The reliable way is an automated alert: sign up free and we’ll email you when a Omeprazole recall is issued.

Are generic Omeprazole recalls common?

Most prescriptions filled in the US are generics, so most recalls involve generic products. A recall doesn’t mean the drug itself is unsafe — it usually affects specific lots or manufacturers.

Is SafeTrack free?

Yes — weekly recall alert digests are free forever, with no credit card required. See pricing.

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