Reported Nov 27, 2024 · Terminated

Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100,…

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · 341 Mason Rd · La Vergne, TN · 37086-3606

Is this the product you have?

    • Guaifenesin Dextromethorphan Syrup
    • 100 mg/10mg per 5 mL
    • Major Pharmaceuticals 8401 Bearing Drive
    • Suite 100
    • Indianapolis
    • IN
    • 46268
    • NDC 0904-7134-70
Lot codes and dates
    • Lot #: C00113
    • Exp. Date 11/2024
    • C00125
    • Exp. Date 04/2025
    • C00145
    • Exp. Date 07/2025
Amount recalled
N/A

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurity/Degradation Specifications

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Mar 5, 2026 · Data as of Sep 19, 8:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.