August 2025 FDA Recall Carvedilol by The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
D-0594-2025 - CGMP Deviations
This Class II drug recall was voluntarily initiated by The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories on August 20, 2025 for the product Carvedilol. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0594-2025
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
08-20-2025
08-27-2025
26,628 cartons
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed nationwide within the United States.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
