Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Guaifenesin Dextromethorphan Syrup Recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories Due to Failed Impurity/Degradation Specifications

Date: November 7, 2024
Company: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories directly.

Affected Products

Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70

Quantity: N/A

Why Was This Recalled?

Failed Impurity/Degradation Specifications

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories has 24 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report