Medications & Supplements/Over-the-Counter

Pfizer Global Supply: Children’s Advil Suspension Recalled Due to Dosage Cup Labeling Error

Agency Publication Date: August 30, 2018

Summary

Pfizer Global Supply is recalling approximately 17,136 bottles of Children’s Advil Suspension (ibuprofen) 4 FL OZ (120 ml). The recall was initiated because the included dosage cup is marked in teaspoons, while the instructions on the bottle’s label are provided in milliliters. This discrepancy between the measuring tool and the instructions could lead to a consumer accidentally providing an incorrect dose of the medication to a child.

Risk

The mismatch between the teaspoon markings on the dosage cup and the milliliter instructions on the label creates a risk of dosage errors. Giving a child too much ibuprofen can lead to serious side effects, while giving too little may fail to treat the child's fever or pain effectively.

What You Should Do

Check your medicine cabinet for 4 FL OZ (120 ml) bottles of Children’s Advil Suspension Ibuprofen Oral Suspension (100 mg per 5mL) with Lot Number R51129 and an expiration date of 11/20.
Verify the UPC code 3-0573-0207-30-0 and NDC 0573-0207-30 located on the product packaging to confirm if your bottle is part of the recall.
Contact your healthcare provider or pharmacist immediately for guidance if you have used this product or have questions about dosing.
Return any unused product to the pharmacy or place of purchase for a full refund.
Contact the manufacturer, Pfizer, for further instructions regarding this recall.
For additional information or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Drug recall remedy

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL (4 FL OZ / 120 ml bottle)

Model:

NDC 0573-0207-30

UPC Codes:

305730207300

Lot Numbers:

R51129 (Exp. 11/20)

Date Ranges: Expiration 11/20

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80876

Status: Resolved

Manufacturer: Pfizer Global Supply

Manufactured In: United States

Units Affected: 17,136 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medicine cabinet for 4 FL OZ (120 ml) bottles of Children’s Advil Suspension Ibuprofen Oral Suspension (100 mg per 5mL) with Lot Number R51129 and an expiration date of 11/20.

Verify the UPC code 3-0573-0207-30-0 and NDC 0573-0207-30 located on the product packaging to confirm if your bottle is part of the recall.

Contact your healthcare provider or pharmacist immediately for guidance if you have used this product or have questions about dosing.

Return any unused product to the pharmacy or place of purchase for a full refund.

Contact the manufacturer, Pfizer, for further instructions regarding this recall.

For additional information or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.