GSK Consumer Health, Inc recalls Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per carton. Distributed by: GSK Consumer
GSK recalls Theraflu Cough Relief due to missing warning for sodium-restricted diets. Check labels for NDC codes and expiration dates to determine if your product is affected.
Lower-risk recall
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.
Contact the company & request your remedy
What happened, in plain English
GSK is recalling Theraflu Cough Relief products because the label lacks a warning for people on sodium-restricted diets. This could lead to unsafe use if someone with such dietary restrictions takes the product without knowing. Read more at govinfonow.com/recall/37497-gsk-theraflu-cough-relief-missing-sodium-warning-label.
Source Summary by GovInfoNow · govinfonow.com/recall/37497-gsk-theraflu-cough-relief-missing-sodium-warning-label · Updated October 5, 2026 · FDA enforcement record: FDA #D-0996-2020
Cite this page
“GSK Theraflu Cough Relief: Missing Sodium Warning Label.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37497-gsk-theraflu-cough-relief-missing-sodium-warning-label. Based on FDA recall #D-0996-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0996-2020%22&limit=1).
Why it’s dangerous
The product label does not include a warning that people on sodium-restricted diets should consult a doctor before use. This could result in unsafe consumption if the product is taken without proper medical guidance.
Who’s affected
People who have a sodium-restricted diet and use the recalled Theraflu Cough Relief products may be at risk. Those with specific dietary restrictions should check their product labels.
How to tell if you have this one
Check for the NDC carton code 0067-6089-01 or packet code 0067-6089-03, and expiration dates up to March 31, 2021 or May 31, 2021. The product was distributed by GSK Consumer Healthcare in Warren, NJ.
- Brand
GSK Consumer Health- Category
Drug
What to do — step by step
Check Label for Warning
Look for a warning statement about sodium-restricted diets on the product label.
Questions people ask
Is this product dangerous for people with high blood pressure?
The recall is specifically for sodium-restricted diets, not high blood pressure. The official notice does not address high blood pressure.
How do I know if my Theraflu is in the recall list?
Check the NDC carton code 0067-6089-01 or packet code 0067-6089-03, and expiration dates up to March 31, 2021 or May 31, 2021.
Do I need to stop using this product?
The recall does not require stopping use; it only requires checking for the missing warning label.
Contact GSK Consumer Health
We’ve drafted a message you can send GSK Consumer Health to request your refund or repair — edit it as you like.
Subject: Recall D-0996-2020 — GSK Consumer Health GSK Consumer Health Hello, I own a GSK Consumer Health that is covered by recall D-0996-2020 from GSK Consumer Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0996-2020 (December 23, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0996-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.