Omeprazole recalls
The FDA has published 12 recalls involving Omeprazole since 2013. The latest was reported on 23 Jul 2025. Most were for labeling errors. Aidapak Services 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 recalls 12 since 2013
Last 12 months 0 reported
Class I 0 0% of total
Ongoing 1 latest 23 Jul 2025
Recalls per month, last 24 months click a bar for that month Severity split
0 0%12 100%0 0%
Why omeprazole is recalled
Ongoing omeprazole recalls 1 active
All omeprazole recalls, newest first 12 total Reported Class Recall Company Reason Where 23 Jul 2025 Drug CLASS II Omeprazole Delayed-release Capsules, USP, 20mg recalled Omeprazole Dr. Reddy's Laboratories Other Nationwide 6 Mar 2024 Drug CLASS II Omeprazole and Sodium Bicarbonate For Oral Suspension recalled Bausch Health Companies Potency & Assay Nationwide 27 Oct 2021 Drug CLASS II Omeprazole Delayed-Release Capsules, 20 mg* recalled Acid Reducer Dr. Reddy's Laboratories Manufacturing (CGMP) Deviations Nationwide 2 Jun 2021 Drug CLASS II Prilosec (Omeprazole Magnesium) For Delayed-Release Oral recalled Prilosec Cardinal Health Manufacturing (CGMP) Deviations FL, GA, SC 31 Mar 2021 Drug CLASS II Omeprazole Delayed Release Capsules, USP, 20 mg recalled Golden State Medical Supply Potency & Assay PA, TX 24 Mar 2021 Drug CLASS II Omeprazole Delayed-Release Capsules, USP, 20 mg recalled Breckenridge Pharmaceutical Potency & Assay Nationwide 6 Feb 2019 Drug CLASS II Omeprazole 4 mg/mL Suspension, 150cc to 300 cc per prescription recalled Duren Health Mart Pharmacy Foreign Material TN 22 Jan 2014 Drug CLASS II Omeprazole/Sodium Bicarbonate, Capsule, 20 mg/110 mg recalled Aidapak Services Labeling Errors 4 states 22 Jan 2014 Drug CLASS II Omeprazole/Sodium Bicarbonate, Capsule, 20 mg/1,100 mg recalled Aidapak Services Labeling Errors 4 states 22 Jan 2014 Drug CLASS II Omeprazole/Sodium Bicarbonate, Capsule, 20 mg/1,110 mg recalled Aidapak Services Labeling Errors 4 states 22 Jan 2014 Drug CLASS II Omeprazole/Sodium Bicarbonate, Capsule, 20 mg/1110 mg recalled Aidapak Services Labeling Errors 4 states 27 Nov 2013 Drug CLASS II Omeprazole Delayed-Release Capsules, USP, 20 mg recalled Omeprazole 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.