Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Theraflu Cough Relief Recalled by GSK Consumer Health, Inc Due to Labeling: Label Lacks Warning: Product recalled due to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact GSK Consumer Health, Inc directly.
Affected Products
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
Quantity: 431,614 cartons
Why Was This Recalled?
Labeling: Label Lacks Warning: Product recalled due to absence of a warning statement on the product label, Ask a doctor before use if you have a sodium-restricted diet.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About GSK Consumer Health, Inc
GSK Consumer Health, Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report