The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100,
Major Pharmaceuticals recalls certain Guaifenesin Dextromethorphan Syrup due to failed impurity specifications. Consumers should check product labels for lot numbers and expiration dates.
Recall notice
Failed Impurity/Degradation Specifications
Contact the company & request your remedy
What happened, in plain English
Major Pharmaceuticals is recalling specific lots of Guaifenesin Dextromethorphan Syrup because the product may contain impurities that could be harmful. This recall affects consumers who have the listed lot numbers and expiration dates. Read more at govinfonow.com/recall/32455-major-pharmaceuticals-guaifenesin-dextromethorphan-syrup-recall-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32455-major-pharmaceuticals-guaifenesin-dextromethorphan-syrup-recall-impurity-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0050-2025
Cite this page
“Major Pharmaceuticals Guaifenesin Dextromethorphan Syrup Recall: Impurity Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32455-major-pharmaceuticals-guaifenesin-dextromethorphan-syrup-recall-impurity-risk. Based on FDA recall #D-0050-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0050-2025%22&limit=1).
Why it’s dangerous
The syrup may contain impurities that could be harmful if consumed. The specific impurities are not detailed in the recall notice, so the exact risk level is unclear.
Who’s affected
Anyone who owns or uses the recalled syrup with lot numbers C00113 (expiring 11/2024), C00125 (expiring 04/2025), or C00145 (expiring 07/2025). Children and adults using the syrup are at risk if the impurities cause harm.
How to tell if you have this one
Check the product label for the lot number: C00113, C00125, or C00145. The expiration dates are 11/2024, 04/2025, and 07/2025 respectively.
- Brand
Major Pharmaceuticals- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide within the United States
| Recall number | Product, codes & lots |
|---|---|
| D-0049-2025 | Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72; Lot #: C00128, Exp. Date 04/2025; C00146, Exp.Date 07/2025 |
| D-0050-2025 | Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70; Lot #: C00113, Exp. Date 11/2024; C00125, Exp. Date 04/2025; C00145, Exp. Date 07/2025 |
What to do — step by step
Check Product Label
Look for the lot number on the label: C00113, C00125, or C00145.
Questions people ask
Is this syrup safe to use?
The recall states the syrup may contain impurities that could be harmful, but the exact risk level is unclear. The manufacturer has not provided specific safety details.
What should I do if I have the recalled syrup?
The recall does not specify a remedy, so the official notice does not state what action to take.
How can I tell if my syrup is recalled?
Check the product label for lot numbers C00113 (expiring 11/2024), C00125 (expiring 04/2025), or C00145 (expiring 07/2025).
Contact Major Pharmaceuticals
We’ve drafted a message you can send Major Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0050-2025 — Major Pharmaceuticals Major Pharmaceuticals Hello, I own a Major Pharmaceuticals that is covered by recall D-0050-2025 from Major Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0050-2025 (November 7, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0050-2025 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.