Carbamazepine Suspension
FDA Recall NDC 51672-4047
Latest: Class II · Status: Ongoing · Initiated Aug 03, 2026 · 2 enforcement reports
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Carbamazepine (NDC 51672-4047). A significant event, classified as Class II, was initiated on Aug 03, 2026 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing"
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
August 2026 Class II Recall: CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Recall Number
Class II Ongoing
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Aug 03, 2026
Aug 26, 2026
1968 Bottles (1000Tablets/Bottle)
Recall Profile & Regulatory Data
Event ID
99562
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.
Batch or Lot Expiration Information
Lot# AD94033, Exp Date: 5/31/2028.
Affected Packages Involved in this Recall
51672-4041-1Carbamazepine
51672-4041-2Carbamazepine
51672-4041-9Carbamazepine
51672-4041-0Carbamazepine
51672-4050-1Carbamazepine
51672-4005-1Carbamazepine
51672-4005-2Carbamazepine
51672-4005-3Carbamazepine
51672-4123-6Carbamazepine
51672-4123-1Carbamazepine
51672-4123-3Carbamazepine
51672-4124-6Carbamazepine
51672-4124-1Carbamazepine
51672-4124-3Carbamazepine
51672-4125-6Carbamazepine
51672-4125-1Carbamazepine
51672-4125-3Carbamazepine
51672-4047-9Carbamazepine
51672-4047-4Carbamazepine
Class III Terminated
Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval.
Oct 21, 2014
Nov 05, 2014
1,966 bottles
Recall Profile & Regulatory Data
Event ID
69413
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Taro Pharmaceuticals U.S.A., Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
IL, OH, LA
Termination Date
Apr 03, 2017
Product Description
Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 26110 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4005-3.
Batch or Lot Expiration Information
Lot# Lot 137393, exp. 10/2016
Affected Packages Involved in this Recall
51672-4041-1Carbamazepine
51672-4041-2Carbamazepine
51672-4041-9Carbamazepine
51672-4041-0Carbamazepine
51672-4050-1Carbamazepine
51672-4005-1Carbamazepine
51672-4005-2Carbamazepine
51672-4005-3Carbamazepine
51672-4123-6Carbamazepine
51672-4123-1Carbamazepine
51672-4123-3Carbamazepine
51672-4124-6Carbamazepine
51672-4124-1Carbamazepine
51672-4124-3Carbamazepine
51672-4125-6Carbamazepine
51672-4125-1Carbamazepine
51672-4125-3Carbamazepine
51672-4047-9Carbamazepine
51672-4047-4Carbamazepine
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.
