Recall
FDAHealthNovember 14, 2024

Zydus Pharmaceuticals (USA) Inc — Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distribu

⚠️ Labeling: Not Elsewhere Classified - Wrong NDC number

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
November 14, 2024

USA Nationwide.

What's affected?

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
Lot code
M408002

Additional details

Lot#: M408002, Exp 05/31/2026

What should I do?

Recommended action

Class III recall. Voluntary: Firm initiated Quantity affected: 4404 packs.

View original FDA notice →

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