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Class II · ModerateRecall completed

Childrens Advil

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: R51129, Exp. 11/20
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byHaleon US Holdings LLC
Brand nameCHILDRENS ADVIL
Generic nameIBUPROFEN
Active ingredient(s)IBUPROFEN
Distributed by / forPfizer Global Supply
NDC0573-0207-30
Show the full FDA record
Full product labelChildren s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ (120 ml) bottle, Pfizer, Madison, NJ 07940 USA, NDC 0573-0207-30, UPC 3-0573-0207-30-0
Recalling firmPfizer Global Supply
DistributionNationwide within the United States
Quantity17,136 bottles
Recall initiated2018-08-23
Report date2018-09-05
Recall completed2021-02-11
Recall numberD-1169-2018
ClassificationClass II
FDA statusTerminated
Origin on fileAndover MA United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.