Medications & Supplements/Over-the-Counter

Major Pharmaceuticals Guaifenesin Dextromethorphan Syrup Recalled for Impurity

Agency Publication Date: November 18, 2024

Summary

The Harvard Drug Group, doing business as Major Pharmaceuticals, is recalling two strengths of Guaifenesin Dextromethorphan Syrup, an over-the-counter medication used to treat cough and chest congestion. The recall was issued because the products failed to meet specific standards for impurities and degradation during testing. Consumers should check their medicine cabinets for the specific brand and lot numbers affected.

Risk

Medications that do not meet purity or degradation specifications may contain unintended substances or lower levels of active ingredients than required. This could potentially reduce the effectiveness of the medication or cause unexpected adverse health effects.

What You Should Do

This recall affects Major Pharmaceuticals Guaifenesin Dextromethorphan Syrup sold in 100 mg/10mg per 5 mL and 200 mg/20mg per 10 mL strengths with NDC codes 0904-7134-70 and 0904-7135-72.
Check your medication for lot numbers C00113, C00125, or C00145 (for the 100mg strength) and lot numbers C00128 or C00146 (for the 200mg strength). The lot numbers are typically printed on the bottle label or carton.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Guaifenesin Dextromethorphan Syrup (200 mg/20mg per 10 mL)by Major Pharmaceuticals

Variants: 200 mg/20mg per 10 mL

Lot Numbers:

C00128 (Exp. Date 04/2025)

C00146 (Exp. Date 07/2025)

NDC:

0904-7135-72

Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268

Product: Guaifenesin Dextromethorphan Syrup (100 mg/10mg per 5 mL)by Major Pharmaceuticals

Variants: 100 mg/10mg per 5 mL

Lot Numbers:

C00113 (Exp. Date 11/2024)

C00125 (Exp. Date 04/2025)

C00145 (Exp. Date 07/2025)

NDC:

0904-7134-70

Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95705

Status: Resolved

Manufacturer: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Sold By: Pharmacies; Drug Stores

Manufactured In: United States

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Major Pharmaceuticals Guaifenesin Dextromethorphan Syrup sold in 100 mg/10mg per 5 mL and 200 mg/20mg per 10 mL strengths with NDC codes 0904-7134-70 and 0904-7135-72.

Check your medication for lot numbers C00113, C00125, or C00145 (for the 100mg strength) and lot numbers C00128 or C00146 (for the 200mg strength). The lot numbers are typically printed on the bottle label or carton.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Guaifenesin Dextromethorphan Syrup (200 mg/20mg per 10 mL)by Major Pharmaceuticals

Variants: 200 mg/20mg per 10 mL

Lot Numbers:

C00128 (Exp. Date 04/2025)

C00146 (Exp. Date 07/2025)

NDC:

0904-7135-72

Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268

Product: Guaifenesin Dextromethorphan Syrup (100 mg/10mg per 5 mL)by Major Pharmaceuticals

Variants: 100 mg/10mg per 5 mL

Lot Numbers:

C00113 (Exp. Date 11/2024)

C00125 (Exp. Date 04/2025)

C00145 (Exp. Date 07/2025)

NDC:

0904-7134-70

Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268