Pfizer Recalls Children's Advil Suspension Due to Dosage Cup Labeling Error
Pfizer is recalling 17,136 bottles of Children's Advil Suspension because the included dosage cup is marked in teaspoons while the label instructions use milliliters.
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 a labeling error that could lead to dosing confusion, fitting the 'Moderate' criteria for minor labeling errors or low-risk issues without reported injuries.
Plain-English summary
Pfizer Global Supply is recalling 17,136 bottles of Children's Advil (Ibuprofen) Oral Suspension, 100 mg per 5 mL, 4 FL OZ (120 mL) bottles. The affected product is identified by Lot # R51129 and an expiration date of 11/20. The recall is due to a labeling error where the included dosage cup is marked in teaspoons, while the instructions on the product label are described in milliliters.
The affected product was distributed nationwide within the United States. This recall is classified as Class II by the FDA, indicating a situation in which there is a reasonable probability that the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have this product should stop using it and contact Pfizer Global Supply for a refund or replacement. The discrepancy between the dosage cup markings and the label instructions could lead to dosing confusion, although no specific injuries or illnesses have been reported in the source text.
The recalled product
- Product
- CHILDRENS ADVIL (IBUPROFEN)
- Brand
- CHILDRENS ADVIL
- Manufacturer
- Pfizer Global Supply
- Category
- Drug — OTC Pain Reliever
- Hazard
- Affected units
- 17,136
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 (2)
- Lot #: R51129
- Exp. 11/20
UPCs (1)
- 305730207300
Distribution
Distributed nationwide across the United States.
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