Omeprazole recalls

The FDA has published 4 recalls involving Omeprazole since 2013. The latest was reported on 23 Jul 2025. Golden State Medical Supply has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls4since 2013

Last 12 months0reported

Class I00% of total

Ongoing1latest 23 Jul 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 1Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 4 100%Class III 0 0%

Why omeprazole is recalled

Other Reasons250%
Potency & Assay250%

Companies

By year

2025125%
2021250%
2013125%

Ongoing omeprazole recalls

1 active

Reported	Class	Recall	Company	Reason	Where
23 Jul 2025Drug	CLASS II	Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole	Dr. Reddy's Laboratories	Other	Nationwide

All omeprazole recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
23 Jul 2025Drug	CLASS II	Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole	Dr. Reddy's Laboratories	Other	Nationwide
31 Mar 2021Drug	CLASS II	Omeprazole Delayed Release Capsules, USP, 20 mg recalled	Golden State Medical Supply	Potency & Assay	PA, TX
24 Mar 2021Drug	CLASS II	Omeprazole Delayed-Release Capsules, USP, 20 mg recalled	Breckenridge Pharmaceutical	Potency & Assay	Nationwide
27 Nov 2013Drug	CLASS II	Omeprazole Delayed-Release Capsules, USP, 20 mg recalledOmeprazole	Kremers Urban Pharmaceuticals	Other	KY, TN

Should you stop taking Omeprazole?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.