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Class III · Lower riskActive recall

Esomeprazole Magnesium

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot#: M408002, Exp 05/31/2026
Where it was soldUSA Nationwide.
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

Labeling: Not Elsewhere Classified - Wrong NDC number

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. 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 nameESOMEPRAZOLE MAGNESIUM
Generic nameESOMEPRAZOLE MAGNESIUM
Active ingredient(s)ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Distributed by / forZydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
NDC68382-849-94
Show the full FDA record
Full product labelEsomeprazole 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
Recalling firmZydus Pharmaceuticals (USA) Inc
DistributionUSA Nationwide.
Quantity4404 packs
Recall initiated2024-11-14
Report date2024-12-11
Recall completed—
Recall numberD-0102-2025
ClassificationClass III
FDA statusOngoing
Origin on filePennington NJ United States

Related

Omeprazole recallsRecent drug recallsCheck another medication

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.