Theraflu Cold and 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 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)
Brand
Novartis Consumer Health
Lot Codes / Batch Numbers
Lot #: Russia product: 10117513, 10117515, 10117517, 10117520, 10118676, 10118680, Exp 6/30/2013 and Former Soviet Union product: 10116986, 10116988, Exp 8/31/2013.
Products Sold
Lot #: Russia product: 10117513,10117515, 10117517, 10117520, 10118676, 10118680, Exp 6/30/2013 and Former Soviet Union product: 10116986, 10116988, Exp 8/31/2013.
Novartis Consumer Health is recalling Theraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 mg and pheniramine malea 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