FDA Recall D-0102-2025

Zydus Pharmaceuticals (USA) Inc · Pennington, NJ

Class III Ongoing 546 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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: Lot#: M408002, Exp 05/31/2026

Quantity: 4404 packs

Reason for recall

Labeling: Not Elsewhere Classified - Wrong NDC number

Recall record

Recall number: D-0102-2025
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: USA Nationwide.
Recall initiated: 2024-11-14
Classified by FDA Center: 2024-12-04
FDA published: 2024-12-11
Recalling firm: Zydus Pharmaceuticals (USA) Inc
Firm location: Pennington, NJ

Drug identification

Brand name(s): ESOMEPRAZOLE MAGNESIUM
Generic name(s): ESOMEPRAZOLE MAGNESIUM
Manufacturer(s): Zydus Pharmaceuticals USA Inc.
NDC(s): 68382-848, 68382-849
Route(s): ORAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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