Reported Nov 27, 2024 · Terminated

Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 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
    • 200 mg/20mg per 10 mL
    • Major Pharmaceuticals 8401 Bearing Drive
    • Suite 100
    • Indianapolis
    • IN
    • 46268
    • NDC 0904-7135-72
Lot codes and dates
    • Lot #: C00128
    • Exp. Date 04/2025
    • C00146
    • 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.

Free recall alerts

Get alerted about new The Harvard Drug Group LLC dba Major… recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

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, 5:05 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.