Esomeprazole recalls
The FDA has published 14 recalls involving Esomeprazole since 2012. The latest was reported on 28 May 2025. Most were for potency & assay. Zydus Pharmaceuticals 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 14 since 2012
Last 12 months 0 reported
Class I 0 0% of total
Ongoing 3 latest 28 May 2025
Recalls per month, last 24 months click a bar for that month Severity split
0 0%7 50%7 50%
Why esomeprazole is recalled
Ongoing esomeprazole recalls 3 active
All esomeprazole recalls, newest first 14 total Reported Class Recall Company Reason Where 28 May 2025 Drug CLASS II Esomeprazole Magnesium for Delayed-Release Oral Suspension recalled Esomeprazole Magnesium Zydus Pharmaceuticals Potency & Assay Nationwide 28 May 2025 Drug CLASS II Esomeprazole Magnesium for Delayed-Release Oral Suspension recalled Esomeprazole Magnesium Zydus Pharmaceuticals Potency & Assay Nationwide 11 Dec 2024 Drug CLASS III Esomeprazole Magnesium for Delayed-Release Oral Suspension recalled Esomeprazole Magnesium Zydus Pharmaceuticals Packaging Defects Nationwide 29 Nov 2023 Drug CLASS III Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg recalled Esomeprazole Magnesium Glenmark Pharmaceuticals Inc., USA Potency & Assay Nationwide 5 Oct 2022 Drug CLASS III Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg recalled Esomeprazole Magnesium SUN Pharmaceutical Industries Potency & Assay Nationwide 5 Oct 2022 Drug CLASS III Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg recalled Esomeprazole Magnesium SUN Pharmaceutical Industries Potency & Assay Nationwide 18 May 2022 Drug CLASS II Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg recalled Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Potency & Assay Nationwide 18 May 2022 Drug CLASS II Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg recalled Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Potency & Assay Nationwide 6 Jan 2021 Drug CLASS II Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg recalled Esomeprazole Magnesium Cipla Packaging Defects Nationwide 6 Jan 2021 Drug CLASS II Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg recalled Esomeprazole Magnesium Cipla Packaging Defects Nationwide 6 Jan 2021 Drug CLASS II Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg recalled Esomeprazole Magnesium Cipla Packaging Defects Nationwide 6 May 2020 Drug CLASS III Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg* recalled Esomeprazole Magnesium Dr. Reddy's Laboratories Other Nationwide 20 Feb 2019 Drug CLASS III Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg* recalled Esomeprazole Magnesium Dr. Reddy's Laboratories Other Nationwide 18 Jul 2012 Drug CLASS III Nexium (esomeprazole magnesium) Delayed-Release Capsules, 40 mg recalled Nexium Astra Zeneca Other Nationwide
Should you stop taking Esomeprazole?
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.