Esomeprazole Magnesium recalls: 12 FDA reports
Recalls involving Esomeprazole Magnesium. What was wrong with each batch, and how the FDA graded the risk.
12Reports
0Class I
3Ongoing
2025-05-28Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx
D-0443-2025 · Class II · reported 2025-05-28 · Ongoing
- Why it was recalled
- Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
- Product
- Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-848-94
- Where it went
- Nationwide -in the USA
- How much
- 22,152 30 sachets/carton
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx
D-0442-2025 · Class II · reported 2025-05-28 · Ongoing
- Why it was recalled
- Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
- Product
- Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94
- Where it went
- Nationwide -in the USA
- How much
- 30,674 30 sachets/carton
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufacture
D-0102-2025 · Class III · reported 2024-12-11 · Ongoing
- Why it was recalled
- Labeling: Not Elsewhere Classified - Wrong NDC number
- Product
- Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets
- Where it went
- USA Nationwide.
- How much
- 4404 packs
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30;
D-0112-2024 · Class III · reported 2023-11-29 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).
- Product
- Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India,
- Where it went
- Nationwide in the USA
- How much
- 8,448 30-count bottles, 168 1000-count bottles
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: O
D-0004-2023 · Class III · reported 2022-10-05 · Terminated
- Why it was recalled
- Superpotent Drug: Out of specification for assay at the 12-month timepoint.
- Product
- Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-734-90.
- Where it went
- Nationwide in the USA
- How much
- 5712 bottles
Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by:
D-0005-2023 · Class III · reported 2022-10-05 · Terminated
- Why it was recalled
- Superpotent Drug: Out of specification for assay at the 12-month timepoint.
- Product
- Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-735-90.
- Where it went
- Nationwide in the USA
- How much
- 8640 bottles
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx only, Manuf
D-0183-2021 · Class II · reported 2021-01-06 · Terminated
- Why it was recalled
- Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
- Product
- Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 NDC 69097-529-34
- Where it went
- U.S.A. Nationwide
- How much
- 6,491 packets
Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets, Rx only, Manuf
D-0182-2021 · Class II · reported 2021-01-06 · Terminated
- Why it was recalled
- Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
- Product
- Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-528-34
- Where it went
- U.S.A. Nationwide
- How much
- 289350 packets
Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manuf
D-0181-2021 · Class II · reported 2021-01-06 · Terminated
- Why it was recalled
- Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
- Product
- Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-527-34
- Where it went
- U.S.A. Nationwide
- How much
- 284,610 packets
Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy'
D-1256-2020 · Class III · reported 2020-05-06 · Terminated
- Why it was recalled
- Discoloration: product contains brown pellets
- Product
- Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA, NDC 43598-510-10
- Where it went
- Nationwide within the United States
- How much
- 1752 bottles
Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 coun
D-0995-2019 · Class III · reported 2019-02-20 · Terminated
- Why it was recalled
- Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
- Product
- Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10), Rx only, Mfd By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA.
- Where it went
- Distributed Nationwide in the USA
- How much
- 40,592, 90 and 1,000 count bottles
Nexium (esomeprazole magnesium) Delayed-Release Capsules, 40 mg, 1000-count bottle, Rx only, Manufactured for:
D-1410-2012 · Class III · reported 2012-07-18 · Terminated
- Why it was recalled
- Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules.
- Product
- Nexium (esomeprazole magnesium) Delayed-Release Capsules, 40 mg, 1000-count bottle, Rx only, Manufactured for: AstraZeneca LP, Wilmington, DE 19850; By: AstraZeneca AB, S-151 85 Sodertalje, Sweden, NDC 0186-5040-85, UPC 3 0186-5040-85 0.
- Where it went
- Nationwide.
- How much
- 2,556 bottles
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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