🔍 RecallPedia

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

Class I - Dangerous
💊 Drugs Recalled: August 20, 2025 The Harvard Drug Group LLC Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #: T05693, Exp. Date 03/2026
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
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
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full 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

Product Codes/Lot Numbers:

Lot #: T05693, Exp. Date 03/2026

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0594-2025

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