FDA Recall Carvedilol

The most recent Recall Enforcement Report that covers this product was initiated on August 20th, 2025 and classified as a Class II recall due to 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, and the associated recall number is recall number is D-0594-2025. It pertains to Carvedilol identified by 0904-7308.

Recall Number D-0594-2025

Event ID

97449 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).

Recall Number

D-0594-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).

Recall Classification

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".

Distribution Pattern

Product was distributed nationwide within the United States. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.

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

Reason For Recall

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm What is the Reason for Recall?
Information describing how the product is defective.

Product Quantity

26,628 cartons Product Quantity
The amount of product subject to recall.

Voluntary Mandated

Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.

Report Date

08-27-2025

Recall Initiation Date

08-20-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.

Initial Firm Notification

Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.

Product Type

Drugs

Recalling Firm

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Code Info/dt>

Lot #: T05693, Exp. Date 03/2026 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.

Recalled NDC Packages

0904-7305-61; 0904-7306-61; 0904-7307-61; 0904-7308-61

Status

Ongoing

View Recall Report

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.