Theraflu MAX-D Severe Cold & Flu (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 MAX-D Severe Cold & Flu (acetaminophen 1000 mg, dextromethorphan HBr 30 mg, guaifenesin 400 mg, pseudoephedrine HCl 60 mg) powder packets, Natural Citrus flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-6427-06, UPC 3 0067-6427-06 5. Also packaged under foreign label: NeoCitran Extra Strength Total 7 Symptom Relief Plus Mucous Relief powder packets, Soothing Lemon flavor, 10-count single dose pouches per carton
Brand
Novartis Consumer Health
Lot Codes / Batch Numbers
Lot #: 10089568, Exp 5/31/2013, 10093324, 10094745, 10097626, 10097627, Exp 7/31/2013, 10098588, Exp 9/30/2013. NeoCitran Extra Strength Total 7 Symptom Relief Plus Mucous Relief : 10093316, Exp 7/31/2013, 10098591, Exp 9/30/2013, 10101027, Exp 10/31/2013, 10102623, Exp 11/30/2013, 10106813, Exp 1/31/2014, 10115844, Exp 6/30/2014, 10124363, Exp 9/30/2014.
Products Sold
Lot #: 10089568, Exp 5/31/2013; 10093324, 10094745, 10097626, 10097627, Exp 7/31/2013; 10098588, Exp 9/30/2013. NeoCitran Extra Strength Total 7 Symptom Relief Plus Mucous Relief : 10093316, Exp 7/31/2013; 10098591, Exp 9/30/2013; 10101027, Exp 10/31/2013; 10102623, Exp 11/30/2013; 10106813, Exp 1/31/2014; 10115844, Exp 6/30/2014; 10124363, Exp 9/30/2014.
Novartis Consumer Health is recalling Theraflu MAX-D Severe Cold & Flu (acetaminophen 1000 mg, dextromethorphan HBr 30 mg, guaifenesin 40 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