Novartis Recalls Theraflu Cold and Flu Powder Packets Due to Foreign Substances
Novartis Consumer Health is recalling specific lots of Theraflu Cold and Flu powder packets because they may contain foreign substances. The recall affects products distributed in the U.S., Mexico, Russia, Korea, Panama, China, and Canada.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
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 2/5 (Moderate).
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 II, which typically involves a situation that may cause temporary or medically reversible adverse health consequences. The hazard is the presence of foreign substances, which is a low-risk contamination issue without reported illnesses.
Plain-English summary
Novartis Consumer Health is recalling specific lots of 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. The recall is due to the potential presence of foreign substances in the product.
The affected products include Russian product lots 10117513, 10117515, 10117517, 10117520, 10118676, and 10118680 (Exp 6/30/2013) and Former Soviet Union product lots 10116986 and 10116988 (Exp 8/31/2013). The products were distributed nationwide in the United States, as well as in Mexico, Russia, Korea, Panama, China, and Canada.
Consumers should check their Theraflu Cold and Flu powder packets for the specific lot numbers and expiration dates listed above. If they have the affected product, they should stop using it and contact Novartis Consumer Health for further instructions or a refund.
The recalled product
- 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)
- Manufacturer
- Novartis Consumer Health
- Category
- Drug — Cold and Flu Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot #: Russia product: 10117513
- 10117515
- 10117517
- 10117520
- 10118676
- 10118680
- Exp 6/30/2013 and Former Soviet Union product: 10116986
- 10116988
- Exp 8/31/2013.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 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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