FDA recall D-0443-2025

Product

Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-848-94

Reason for recall

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.

Distribution

Nationwide -in the USA

Key facts

Status

Ongoing

Initiation date

2025-05-13

Report date

2025-05-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0443-2025