Recall: D-0675-2025

Class II - Potentially Harmful

Class IIClassification

2025-09-15Initiated

OngoingStatus

Amerisource Health Services LLFirm

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

Failed Dissolution Specifications.

Distribution

Nationwide in the USA.

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