Use caution Drug recall · FDA · Published May 13, 2025

Zydus Recalls Esomeprazole Magnesium Due to Impurity Issues

Zydus Pharmaceuticals recalls specific lots of Esomeprazole Magnesium 20 mg single dose packets due to failed impurity specifications.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0443-2025Drug Zydus ›

Use caution until it’s fixed

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.

Take action

Contact the company

Recalling firmZydus Pharmaceuticals (USA) Inc73 Route 31 N · Pennington, NJ 08534-3601

✎ GovInfoNow plain-language explainer

Zydus Pharmaceuticals (USA) Inc. is recalling Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, in 30-count single dose packets. The recall was initiated because out-of-specification test results were obtained for unknown degradation products during long-term stability testing. This means the drug may not meet its labeled quality standards. Read more at govinfonow.com/recall/32079-zydus-recalls-esomeprazole-magnesium-due-to-impurity-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/32079-zydus-recalls-esomeprazole-magnesium-due-to-impurity-issues · Updated October 9, 2026 · FDA enforcement record: FDA #D-0443-2025

Cite this page

“Zydus Recalls Esomeprazole Magnesium Due to Impurity Issues.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32079-zydus-recalls-esomeprazole-magnesium-due-to-impurity-issues. Based on FDA recall #D-0443-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0443-2025%22&limit=1).

The FDA announced on May 13, 2025, that Zydus Pharmaceuticals (USA) Inc is recalling Esomeprazole Magnesium for Delayed-Release Oral Suspension due to failed impurity specifications. The agency stated the recall addresses out-of-specification test results for unknown degradation products.

How to tell if you have it

Brand: Zydus
Product: Esomeprazole Magnesium 20 mg
NDC: 68382-848-94
Lot M402147, Exp 10/2025
Lot M311637, Exp 07/2025
Lot M402495, Exp 02/2026
Lot M407997, Exp 05/2026
Lot M502246, Exp11/2026

The hazard

The recall addresses failed impurities and degradation specifications. Specifically, out-of-specification test results were obtained for any individual unknown degradation product during Related Compounds testing during long term stability.

Context

GovInfoNow's records show Zydus Pharmaceuticals (USA) Inc has 53 other recalls on record since 2012-03-14. Other recent recalls of similar products include Zydus Mirabegron 25mg Tablets Recall (2026-08-05), Zydus Erythromycin Tablets Recall (2026-04-29), and Zydus Recalls Icosapent Ethyl Capsules Due to Defects (2026-03-09). Other recent recalls of similar products include Rising Pharma Recalls Temozolomide 5mg Capsules Due to Impurity Issues (2026-03-03), Novadoz Glycopyrrolate Oral Solution Recall (2025-12-15), and Somerset Therapeutics Dexamethasone Injection Recall (2026-02-04).

How to tell if you have this one

Check your medication box for NDC 68382-848-94 and one of the following lot numbers with their corresponding expiration dates: M402147 (Exp 10/2025), M311637 (Exp 07/2025), M402495 (Exp 02/2026), M407997 (Exp 05/2026), or M502246 (Exp 11/2026). The product is Rx Only and was distributed nationwide in the USA.

Brand
Zydus
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide -in the USA
NDC
68382-848-94, 68382-849-94

Recall number	Product, codes & lots	Quantity
D-0442-2025	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; Lot # M311638, Exp 07/2025, M400374, Exp 10/2025, M402496, Exp 02/2026, M407998, Exp 05/2026, M502247, Exp 11/2026, M414770, M414512, Exp 09/2026.	30,674 30 sachets/carton
D-0443-2025	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; Lot #:M402147, Exp 10/2025; M311637, Exp 07/2025; M402495, Exp 02/2026; M407997, Exp 05/2026; M502246, Exp11/2026.	22,152 30 sachets/carton

Based on the official FDA remedy

What to do — step by step

Check Your Medication
Verify if your Esomeprazole Magnesium packets match the NDC and lot numbers listed in the recall notice.
Contact Your Pharmacist
If you have one of the affected lots, contact your pharmacist or healthcare provider for instructions on replacement or disposal.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide -in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 15 days after the firm started it.

May 13, 2025Firm started the recall
May 20, 2025FDA classified it Class II
May 28, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/32079-zydus-recalls-esomeprazole-magnesium-due-to-impurity-issues">Zydus Recalls Esomeprazole Magnesium Due to Impurity Issues (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0443-2025 (May 13, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0443-2025 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.