Carbamazepine Tablet, Extended Release
FDA Recall NDC 60687-583
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Carbamazepine (NDC 60687-583). A significant event, classified as Class II, was initiated on Sep 15, 2025 by American Health Packaging. The reported reason for this action was: "Failed Dissolution Specifications."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Dissolution Specifications.
Sep 15, 2025
Oct 08, 2025
360 cartons
Recall Profile & Regulatory Data
Event ID
97634
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amerisource Health Services LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
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)
Batch or Lot Expiration Information
Lot# : 1024078, Exp. Date 08/31/2026
Affected Packages Involved in this Recall
60687-583-11Product
60687-583-21Product
60687-594-11Product
60687-594-21Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
