Skip to main content

Omeprazole

FDA recalls

3 rows

DateCompany and reasonClass
Jun 29, 2025Dr. Reddy's Laboratories, Inc.
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Class II · Ongoing
Oct 4, 2021Dr. Reddy's Laboratories, Inc.
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Class II · Terminated
Sep 15, 2013Kremers Urban Pharmaceuticals, Inc.
Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.
Class II · Terminated

← Back to Omeprazole

Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).