Medications & Supplements/Over-the-Counter

Safe Tussin Cough Syrups Recalled for Potential Lubricant Contamination

Agency Publication Date: July 24, 2023

Summary

Safe Tussin DM Cough + Chest Congestion (dextromethorphan HBr and guaifenesin) and Safe Tussin PM Night Time Cough Relief (cough suppressant and antihistamine) are being recalled by Kramer Laboratories, Inc. The recall was issued because a non-food grade industrial lubricant was used in the mixing vessel during the manufacturing process, which could contaminate the medicine. No injuries or illnesses have been reported to date in connection with this issue.

Risk

Ingesting product contaminated with industrial lubricant poses a potential health risk to consumers. The medicine was manufactured in equipment using non-food grade lubricants, violating quality standards.

What You Should Do

This recall affects Safe Tussin DM Cough + Chest Congestion and Safe Tussin PM Night Time Cough Relief sold in 4.0 FL OZ (118mL) bottles.
Identify affected DM Cough + Chest Congestion bottles by checking for lot numbers 8753 or 8753A (Expiration 10/2023) and lot 8659 (Expiration 8/2023).
Identify affected PM Night Time Cough Relief bottles by checking for lot number 8639 (Expiration 8/2023).
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 Kramer Laboratories, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Safe Tussin DM Cough + Chest Congestion (4.0 FL OZ)

Variants: Dextromethorphan HBr/Cough Suppressant, Guaifenesin/Expectorant

Lot Numbers:

8753 (Exp. Date 10/2023)

8753A (Exp. Date 10/2023)

8659 (Exp. Date 8/2023)

Recall #: D-0942-2023

Product: Safe Tussin PM Night Time Cough Relief (4.0 FL OZ)

Variants: Cough Suppressant/Antihistamine

Lot Numbers:

8639 (Exp. Date 8/2023)

Recall #: D-0943-2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92407

Status: Resolved

Manufacturer: Kramer Laboratories, Inc.

Sold By: retail pharmacies; nationwide retailers

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 Safe Tussin DM Cough + Chest Congestion and Safe Tussin PM Night Time Cough Relief sold in 4.0 FL OZ (118mL) bottles.

Identify affected DM Cough + Chest Congestion bottles by checking for lot numbers 8753 or 8753A (Expiration 10/2023) and lot 8659 (Expiration 8/2023).

Identify affected PM Night Time Cough Relief bottles by checking for lot number 8639 (Expiration 8/2023).

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 Kramer Laboratories, Inc. for further instructions.

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

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: Safe Tussin DM Cough + Chest Congestion (4.0 FL OZ)

Variants: Dextromethorphan HBr/Cough Suppressant, Guaifenesin/Expectorant

Lot Numbers:

8753 (Exp. Date 10/2023)

8753A (Exp. Date 10/2023)

8659 (Exp. Date 8/2023)

Recall #: D-0942-2023

Product: Safe Tussin PM Night Time Cough Relief (4.0 FL OZ)

Variants: Cough Suppressant/Antihistamine

Lot Numbers:

8639 (Exp. Date 8/2023)

Recall #: D-0943-2023