Class II · ModerateActive recall

Esomeprazole Magnesium

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?

Check your lot numberLot # 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.

Where it was soldNationwide -in the USA

Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

Check the lot number and expiry on your medicine against the recall above.
Talk to your pharmacist or doctor before changing anything — don't stop on your own.
Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byZydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534 foreign manufacturer

Brand name	ESOMEPRAZOLE MAGNESIUM
Generic name	ESOMEPRAZOLE MAGNESIUM
Active ingredient(s)	ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Distributed by / for	Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
NDC	68382-849-94

Show the full FDA record

Full product label	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
Recalling firm	Zydus Pharmaceuticals (USA) Inc
Distribution	Nationwide -in the USA
Quantity	30,674 30 sachets/carton
Recall initiated	2025-05-13
Report date	2025-05-28
Recall completed	—
Recall number	D-0442-2025
Classification	Class II
FDA status	Ongoing
Origin on file	Pennington NJ United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.