FDA Drug recall D-0996-2020
Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per carton
- FDA Drug
- Class II
- terminated
- Published 2020-02-19
On 2020-02-19 the FDA classified a Class II recall of Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per carton by Gsk Consumer Health, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0996-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-23 |
| Published | 2020-02-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Gsk Consumer Health |
| Distribution | US |
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
Reason
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.
Identifiers
| code_info | Lot: K79A, K79B, K79C, exp 3/31/2021; XB2W, Y23L, Y23V, exp 5/31/2021; 19N1793000, 19N1895942, 19N1952247, 19N1884668,…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0996-2020%22
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