Theraflu Cold and Flu — Class II drug recall D-763-2014
Terminated recall by Novartis Consumer Health, reported 2014-01-29, distributed nationwide. Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
| Recall number | D-763-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novartis Consumer Health, Lincoln, NE, United States |
| Recall initiated | 2013-06-18 |
| Classified | 2014-01-17 |
| Reported by FDA | 2014-01-29 |
| Terminated | 2014-11-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, KR, MX, PA, RU |
| Expiration dates | 2013-06-30, 2013-08-31 |
Product
Theraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 mg and pheniramine maleate 20 mg) powder packets, Forest Berries flavor, 10-count packets per box, UPC 4 607045 191760. (Russian product and Former Soviet Union product)
Reason for recall
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
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-763-2014. 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.