Theraflu Flu & Sore Throat — Class II drug recall D-748-2014
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-748-2014 |
|---|---|
| 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 |
| Quantity | 1,614,564 cartons |
| UPC / GTIN / UDI-DI | 00058478052052 |
| NDC | 00043-0479-16, 00067-7916-06 |
| Lot numbers | 10115121, 10115832, 10119854, 10119856, 10122257, 10124286, 10124289, 10124292, 10128103, 10128105, 10128108, 10128110 |
| Expiration dates | 2013-05-31, 2013-07-31, 2013-09-30, 2013-10-31 |
Product
Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Apple Cinnamon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-7916-06, UPC 3 0043-0479-16 3. Also packaged under foreign label: NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Apple Cinnamon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05205 2.
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-748-2014. 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.