Carvedilol Tablet, Film Coated
FDA Recall NDC 0904-7308
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 Carvedilol (NDC 0904-7308). A significant event, classified as Class II, was initiated on Aug 20, 2025 by Major Pharmaceuticals. The reported reason for this action was: "CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm"
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: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Aug 20, 2025
Aug 27, 2025
26,628 cartons
Recall Profile & Regulatory Data
Event ID
97449
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed nationwide within the United States.
Product Description
Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61
Batch or Lot Expiration Information
Lot# : T05693, Exp. Date 03/2026
Affected Packages Involved in this Recall
0904-7305-61Product
0904-7306-61Product
0904-7307-61Product
0904-7308-61Product
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.
