Novartis Recalls Theraflu Warming Relief Due to Unknown Degradant
Novartis Consumer Health is recalling Theraflu Warming Relief caplets because an unknown degradant was found during stability testing.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text explicitly states the agency classification is Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Novartis Consumer Health, Inc. is recalling Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg. The recall involves 8-caplet and 24-caplet packages distributed nationwide and in Mexico, Panama, Ecuador, and Venezuela.
The recall was initiated because an unknown degradant was found during stability testing. The agency has classified this as a Class III recall, indicating that the product is unlikely to cause adverse health consequences.
Consumers should stop using the affected products and return them to the place of purchase for a refund or contact Novartis Consumer Health for further instructions.
The recalled product
- Product
- Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in a) 8 coated caplets (NDC 0067-6438-08) b) 24 coated caplets (NDC 0067-6438-24), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ.…
- Manufacturer
- Novartis Consumer Health
- Hazard
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Novartis Consumer Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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