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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Over-the-Counter

Glaxosmithkline Consumer Healthcare Holdings: Children's Robitussin and Dimetapp Recalled for Defective Dosing Cups

Agency Publication Date: June 26, 2020
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Summary

Approximately 210,468 bottles of Children's Robitussin Honey Cough and Chest Congestion DM and Children's Dimetapp Cold & Cough are being recalled because the included dosing cups are missing graduation marks. Without these marks, parents or caregivers may provide incorrect dosages to children. Consumers should immediately stop using the dosing cups provided with the affected lots of these medications and contact their healthcare provider or pharmacist for guidance. These products were distributed nationwide across the United States between 2020 and 2022.

Risk

The missing markings on the dosing cups can lead to accidental underdosing or overdosing of the medication. Overdosing these specific cough and cold ingredients in children can lead to serious adverse health effects including respiratory depression or seizures.

What You Should Do

  1. Check your medicine cabinet for 4 FL OZ (118 mL) bottles of Children's Robitussin Honey Cough and Chest Congestion DM with UPC 50300318760128 and Lot numbers 02177 or 02178 (Exp. 01/31/2022).
  2. Check your medicine cabinet for 8 FL OZ (237 mL) bottles of Children's Dimetapp Cold & Cough with UPC 60300312234196 and Lot number CL8292 (Exp. 09/30/2021).
  3. Immediately stop using the dosing cup included with these specific recalled products to avoid incorrect dosing.
  4. Contact your healthcare provider or pharmacist for guidance regarding the appropriate medication and dosage for your child.
  5. Return any unused product to the pharmacy or place of purchase for a refund and contact Glaxosmithkline Consumer Healthcare Holdings at 1-888-723-3332 for further instructions.
  6. If you have additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug recall remedy

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Childrens Robitussin Honey Cough and Chest Congestion DM (4 FL OZ)
Model:
NDC: 0031-8760-12
UPC Codes:
50300318760128
Lot Numbers:
02177 (Exp. 01/31/2022)
02178 (Exp. 01/31/2022)
Date Ranges: Expiration: 01/31/2022
Product: Childrens Dimetapp Cold & Cough (8 FL OZ)
Model:
NDC: 0031-2234-19
UPC Codes:
60300312234196
Lot Numbers:
CL8292 (Exp. 09/30/2021)
Date Ranges: Expiration: 09/30/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85848
Status: Resolved
Manufacturer: Glaxosmithkline Consumer Healthcare Holdings
Manufactured In: United States, Canada
Units Affected: 2 products (132,336 bottles; 78,132 bottles)
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 ยท 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.