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 for recall: Labeling: Not Elsewhere Classified - Wrong NDC number
Recall initiated: 20241114
Status: Ongoing
Classification: Class III
Recall type: Voluntary: Firm initiated