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

GSK Consumer Health, Inc: Theraflu Cough Relief Recalled for Missing Sodium Warning Label

Agency Publication Date: February 13, 2020
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Summary

GSK Consumer Health, Inc. is recalling approximately 431,614 cartons of Theraflu Cough Relief (dextromethorphan HBr and guaifenesin) because the packaging is missing a required warning label. The label fails to instruct consumers to ask a doctor before use if they are on a sodium-restricted diet. This recall affects 6-packet cartons distributed nationwide in the United States. Consumers should check their medicine cabinets for the specific lot numbers and expiration dates listed below.

Risk

The product lacks a mandatory warning for individuals on sodium-restricted diets, which could lead to excessive sodium intake. This poses a potential health risk to consumers with conditions such as hypertension or kidney disease who must carefully manage their sodium levels.

What You Should Do

  1. Check your medicine cabinet for Theraflu Cough Relief (Dextromethorphan HBr and Guaifenesin) in 6-packet cartons with NDC 0067-6089-01.
  2. Verify if your product matches one of the following lot numbers and expiration dates: K79A, K79B, K79C (Exp 3/31/2021); XB2W, Y23L, Y23V (Exp 5/31/2021); 19N1793000, 19N1895942, 19N1952247, 19N1884668, 19N1936498, 19N1936583 (Exp 3/31/2021); 19N1920630, 19N1958240 (Exp 4/30/2021); 19N1957675, M926001MA, M926002MA, M926003MA, M926004MA, M926005MA, M926006MA, M926007MA, M926008MA, M926009MA, M926201MA, M926202MA (Exp 5/31/2021); or M926201MB, M926202MB, M926203MB, M926204MB, M926205MB, M926206MB, M926207MB, M926208MB, M926209MB (Exp 2/28/2021).
  3. If you are on a sodium-restricted diet, do not use the affected product and consult your healthcare provider or pharmacist for guidance.
  4. Return any unused product to the place of purchase for a full refund or contact GSK Consumer Health at the address in Lincoln, Nebraska for further instructions.
  5. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Full refund available for affected products.

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

Affected Products

Product: Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin (6 packets per carton)
Model:
NDC carton: 0067-6089-01
NDC packet: 0067-6089-03
Lot Numbers:
K79A (Exp 3/31/2021)
K79B (Exp 3/31/2021)
K79C (Exp 3/31/2021)
XB2W (Exp 5/31/2021)
Y23L (Exp 5/31/2021)
Y23V (Exp 5/31/2021)
19N1793000 (Exp 3/31/2021)
19N1895942 (Exp 3/31/2021)
19N1952247 (Exp 3/31/2021)
19N1884668 (Exp 3/31/2021)
19N1936498 (Exp 3/31/2021)
19N1936583 (Exp 3/31/2021)
19N1920630 (Exp 4/30/2021)
19N1958240 (Exp 4/30/2021)
19N1957675 (Exp 5/31/2021)
M926001MA (Exp 5/31/2021)
M926002MA (Exp 5/31/2021)
M926003MA (Exp 5/31/2021)
M926004MA (Exp 5/31/2021)
M926005MA (Exp 5/31/2021)
M926006MA (Exp 5/31/2021)
M926007MA (Exp 5/31/2021)
M926008MA (Exp 5/31/2021)
M926009MA (Exp 5/31/2021)
M926201MA (Exp 5/31/2021)
M926202MA (Exp 5/31/2021)
M926201MB (Exp 2/28/2021)
M926202MB (Exp 2/28/2021)
M926203MB (Exp 2/28/2021)
M926204MB (Exp 2/28/2021)
M926205MB (Exp 2/28/2021)
M926206MB (Exp 2/28/2021)
M926207MB (Exp 2/28/2021)
M926208MB (Exp 2/28/2021)
M926209MB (Exp 2/28/2021)
Date Ranges: Exp 3/31/2021, Exp 5/31/2021, Exp 4/30/2021, Exp 2/28/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84931
Status: Resolved
Manufacturer: GSK Consumer Health, Inc
Manufactured In: United States
Units Affected: 431,614 cartons
Distributed To: Nationwide
Agency Last Updated: March 7, 2020

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.