Novartis Recalls Excedrin Sinus Headache Caplets Due to Unknown Degradant
Novartis Consumer Health is recalling Excedrin Sinus Headache caplets because an unknown degradant was found during stability testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The hazard is an unknown degradant found during stability testing, which fits the criteria for a moderate severity score due to the precautionary nature of the recall without reported injuries.
Plain-English summary
Novartis Consumer Health is recalling specific lots of Excedrin Sinus Headache caplets. The product contains acetaminophen 325mg and phenylephrine HCL 5mg. The recall was initiated because an unknown degradant was identified during stability testing.
The affected product is distributed by Novartis Consumer Health, Inc., in Parsippany, NJ. The recall covers 2,978,000 two-caplet packages. Distribution was made nationwide and in Mexico, Panama, Ecuador, and Venezuela. The specific lot numbers and expiration dates are listed in the recall details.
Consumers should check their medication for the affected lot numbers and expiration dates. If the product matches the recalled lots, consumers should stop using it and contact their healthcare provider or the manufacturer for instructions on disposal or replacement.
The recalled product
- Product
- Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2062-02.
- 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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