FDA recall D-0675-2025

Product

Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11)

Reason for recall

Failed Dissolution Specifications.

Distribution

Nationwide in the USA.

Key facts

Status

Ongoing

Initiation date

2025-09-15

Report date

2025-10-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0675-2025