Carbamazepine Tablet
FDA Recall NDC 51407-215
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 51407-215). A significant event, classified as Class II, was initiated on Aug 07, 2026 by Golden State Medical Supply, Inc.. The reported reason for this action was: "CGMP deviations: tablets with black specks."
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
CGMP deviations: tablets with black specks.
Aug 07, 2026
Aug 26, 2026
1200 bottles
Recall Profile & Regulatory Data
Event ID
99614
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Golden State Medical Supply Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10), b) 100-count bottles (NDC 51407-215-01), Rx Only, Manufactured by: Taro Pharmaceutical Industries Ltd., Marketed by: GSMS, Incorporated, Camarillo, CA 93012 USA
Batch or Lot Expiration Information
Lot# : a) GS067429, GS068091, Exp 5/31/2028; b) GS067430, GS068090, Exp 5/31/2028
Affected Packages Involved in this Recall
51407-215-01Product
51407-215-10Product
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.
