Recall: D-0102-2025

Class III - Minor Violations

Class IIIClassification

2024-11-14Initiated

OngoingStatus

Zydus Pharmaceuticals (USA) InFirm

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

Reason

Labeling: Not Elsewhere Classified - Wrong NDC number

Distribution

USA Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.