Theraflu Cough Relief Recalled for Missing Sodium Warning
GSK is recalling Theraflu Cough Relief packets because the label lacks a warning for people on sodium-restricted diets.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (missing warning) rather than a direct contamination or structural defect, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
GSK Consumer Health, Inc. is recalling 431,614 cartons of Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per carton. The product was distributed nationwide in the USA.
The recall was initiated because the product label is missing a required warning statement: "Ask a doctor before use if you have a sodium-restricted diet." This omission could be a risk for consumers who need to monitor their sodium intake.
Consumers with this product should stop using it and contact GSK Consumer Healthcare for a refund or further instructions. The affected lots include K79A, K79B, K79C, XB2W, Y23L, Y23V, and various 19N and M926 series lots with expiration dates ranging from February 2021 to May 2021.
The recalled product
- Product
- Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per carton. Distributed by: GSK Consumer Healthcare, Warren, NJ 07059. NDC carton: 0067-6089-01, NDC packet: 0067-6089-03
- Manufacturer
- GSK Consumer Health, Inc
- Category
- Drug — OTC Cough Medicine
- Hazard
- Affected units
- 431,614
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot: K79A
- K79B
- K79C
- exp 3/31/2021
- XB2W
- Y23L
- Y23V
- exp 5/31/2021
- 19N1793000
- 19N1895942
- 19N1952247
- 19N1884668
- 19N1936498
- 19N1936583
- 19N1920630
- 19N1958240
- exp 4/30/2021
- 19N1957675
- M926001MA
- M926002MA
Distribution
Distributed nationwide across the United States.
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