Vicks NyQuil Liquid Recalled for Incorrect Undeclared Excipients Labeling
Procter & Gamble is recalling Vicks NyQuil Cold and Flu Nighttime Relief Liquid Twin Packs because the outer wrap incorrectly identifies color additives.
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 and involves minor labeling errors regarding undeclared color additives, which fits the rubric for moderate severity.
Plain-English summary
Procter & Gamble is recalling 11,337 twin packs of Vicks NyQuil Cold and Flu Nighttime Relief, Liquid Twin Pack. The product is a 12 fl oz (354 ml) bottle containing Acetaminophen 650mg, Dextromethorphan HBr 30mg, and Doxylamine succinate 12.5mg. The recall is due to incorrect and undeclared excipients, specifically because the NyQuil Liquid Original bottles were inadvertently overwrapped with NyQuil Liquid Cherry information. As a result, the outer wrap does not correctly identify the color additives, particularly FD&C Yellow No. 6 and FD&C Yellow 10.
The affected products were distributed nationwide. The specific lot numbers for the twin packs are 31614334R1 and 31814334R1, with an expiration date of 5/15. Additionally, twin packs further packaged in displays received by WalMart only are affected, with display lot numbers 3051A152HK, 3051A152HL, 3051A152HM (all Exp 1/15), and 30746493F5 (Exp 2/15).
Consumers should check their Vicks NyQuil Cold and Flu Nighttime Relief Liquid Twin Packs for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, consumers should stop using it and contact Procter & Gamble or the retailer for a refund or replacement.
The recalled product
- Product
- Vicks NyQuil Cold and Flu Nighttime Relief, Liquid Twin Pack, (Acetaminophen 650mg, Dextromethorphan HBr 30mg, Doxylamine succinate 12.5mg), 12 fl oz (354 ml) bottles, Distributed by Procter & Gamble, Cincinnati, OH 45202, NDC 37000-807-12
- Manufacturer
- Procter & Gamble Co
- Category
- Drug — OTC Cold and Flu
- Affected units
- 11,337
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 #s 31614334R1
- 31814334R1
- Exp 5/15
- Exp 1/15
- 3051A152HL
- Exp. 1/15
- 3051A152HM
- 30746493F5
- Exp 2/15
Distribution
Distributed nationwide across the United States.
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