Theraflu (Novartis) – foreign substance risk (2013)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, labeled as a) Theraflu Sinus & Cold (NDC 0067-6319-06, UPC 3 0043-6319-06 7) and b) Theraflu Cold & Sore Throat (NDC 0067-6716-06, UPC 3 0043-0467-16 0). Also packaged under foreign labels: NeoCitran Cold & Flu powder packets, Natural Source Lemon flavor, 10-co
Brand
Novartis Consumer Health
Lot Codes / Batch Numbers
Lot #: a) 10116014, Exp 6/30/2013, 10122246, Exp 7/31/2013, 10124322, Exp 9/30/2013, 10128122, Exp 11/30/2013, b) 10119852, Exp 7/31/2013, 10122249, Exp 8/31/2013, 10124321, Exp 9/30/2013, 10128118, Exp 11/30/2013, 10128120, Exp 11/30/2013. NeoCitran Cold & Flu: 10115576, Exp 6/30/2013, 10122243, Exp 8/31/2013 and 10124319, Exp 9/30/2013, Theraflu Exthegran 10115579, 10115572, Exp 6/30/2013, 10117549, Exp 8/30/2013.
Products Sold
Lot #: a) 10116014, Exp 6/30/2013; 10122246, Exp 7/31/2013; 10124322, Exp 9/30/2013; 10128122, Exp 11/30/2013; b) 10119852, Exp 7/31/2013; 10122249, Exp 8/31/2013; 10124321, Exp 9/30/2013; 10128118, Exp 11/30/2013; 10128120, Exp 11/30/2013. NeoCitran Cold & Flu: 10115576, Exp 6/30/2013; 10122243, Exp 8/31/2013 and 10124319, Exp 9/30/2013; Theraflu Exthegran 10115579, 10115572, Exp 6/30/2013; 10117549, Exp 8/30/2013.
Novartis Consumer Health is recalling Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder due to Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026