CLASS II Drug recall · Reported 19 Feb 2020 · FDA Enforcement Report
Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin recalled
GSK Consumer Health is recalling Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per, distributed nationwide in the US. The recall was initiated on 23 Dec 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0996-2020
- FDA event ID
- 84931
- Recalling firm
- GSK Consumer Health, Lincoln, NE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Dec 2019
- FDA classified
- 7 Mar 2020
- Reported
- 19 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Cold & Cough Medicine
Timeline
| 23 Dec 2019 | Recall initiated by company | |
| 19 Feb 2020 | Published in enforcement report | +58 days |
| 7 Mar 2020 | Classified by FDA | +17 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for 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.
Product as listed by the FDA
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
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it 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.
Which lots are affected?
Lot: 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; M926201MB, M926202MB, M926203MB, M926204MB, M926205MB, M926206MB, M926207MB, M926208MB, M926209MB, exp 2/28/2021
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.