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)
FDA recall notice · announced October 8, 2025 · Amerisource Health Services
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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.
Notes
Distribution: Nationwide in the USA.
Lot/code information: Lot #: 1024078, Exp. Date 08/31/2026
Quantity: 360 cartons
Status: Ongoing
Products in this recall event:
- 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: (D-0675-2025)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.