Theraflu Cough Relief — Class II drug recall D-0996-2020
Terminated recall by GSK Consumer Health, Inc, reported 2020-02-19, distributed nationwide. Labeling: Label Lacks Warning: Product recalled due to absence of a warning statement on the product label, As
| Recall number | D-0996-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GSK Consumer Health, Inc, Lincoln, NE, United States |
| Recall initiated | 2019-12-23 |
| Classified | 2020-03-07 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2023-03-09 |
| Distributed | Nationwide (US) |
| Quantity | 431,614 cartons |
| Reason classes | labeling |
| NDC | 00067-6089-01, 00067-6089-03 |
| Lot numbers | 19N1793000, 19N1884668, 19N1895942, 19N1920630, 19N1936498, 19N1936583, 19N1952247, 19N1957675, 19N1958240, K79A, K79B, K79C, M926001MA, M926002MA, M926003MA, M926004MA, M926005MA, M926006MA, M926007MA, M926008MA, M926009MA, M926201MA, M926201MB, M926202MA, M926202MB, M926203MB, M926204MB, M926205MB, M926206MB, M926207MB, M926208MB, M926209MB, XB2W, Y23L, Y23V |
| Expiration dates | 2021-02-28, 2021-03-31, 2021-04-30, 2021-05-31 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0996-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.