FDA recall D-0102-2025

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

Distribution

USA Nationwide.

Key facts

Status

Ongoing

Initiation date

2024-11-14

Report date

2024-12-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0102-2025