CARBAMAZEPINE
Recalling Firm / Manufacturer: Amerisource Health Services LLC
(Columbus, OH, United States)
FDA Recall Number: D-0675-2025
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
CARBAMAZEPINE
Generic Name
CARBAMAZEPINE
Active Substance(s)
Carbamazepine
Administration Route
Oral
National Drug Code (NDC)
60687-583
Total Quantity Recalled
360 cartons
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Failed Dissolution Specifications.
Full Product Description
Packaging specifications and labeling details
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)
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
October 08, 2025
Firm Initiation Date
September 15, 2025
FDA Classification Date
Sep 29, 2025
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot #: 1024078, Exp. Date 08/31/2026
Distribution Information
Geographic scope of affected shipments
Nationwide in the USA.
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0675-2025
Questo Retrieval Date: July 31, 2026 14:36 1785508613UTCC