Class IIIReported 2024-12-11

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

Recalled by Zydus Pharmaceuticals (USA) Inc

Reason for Recall

Labeling: Not Elsewhere Classified - Wrong NDC number

Recall Number

D-0102-2025

Classification

Class III

Status

Ongoing

Category

drug

Initiated

2024-11-14

Reported

2024-12-11

Distribution

USA Nationwide.

Code Info

Lot#: M408002, Exp 05/31/2026

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.