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Omeprazole recalls

Omeprazole products have been recalled 2 times, most recently on 23 Jul 2025. The recalling company is usually Kremers Urban Pharmaceuticals.

Total recalls2since 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 2 100%Class III 0 0%

Why omeprazole is recalled

Other Reasons2100%

Companies

Product types

Stomach & Acid Reflux Medication2100%

By year

2025150%
2013150%

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

2 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
27 Nov 2013Drug	CLASS II	Omeprazole Delayed-Release Capsules, USP, 20 mg recalledOmeprazole	Kremers Urban Pharmaceuticals	Other	KY, TN

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.