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Class II · ModerateRecall completed

Infants Advil

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

Does this affect you?
Check your lot numberBatch/Lot # R73761, exp. date 01/31/2021, Item # F00573019175, 0.75 oz. R74936, exp. date 02/28/2021, Item # F00573019175, 0.75 oz. R56290, exp. date 03/31/2020, Item # F00573019150, 1 oz. R60959, exp. date 02/28/2021, Item # F00573019150, 1 oz. R78826, exp. date 11/30/2021, Item # F00573019150, 1 oz. 9335UA, exp. date 01/31/2021, item # F00573019175A - Co-package 9336UA, exp. date 02/28/2021, item # F00573019175A - Co-package
Where it was soldProduct was distributed throughout the United States, including Puerto Rico.
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: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

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 nameINFANTS ADVIL
Generic nameIBUPROFEN
Active ingredient(s)IBUPROFEN
Distributed by / forGlaxosmithkline Consumer Healthcare Holdings
NDC0573-0191-75
Show the full FDA record
Full product labelIbuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC 0573-0191-75 (0.75 oz.) NDC 0573-0191-50 (1 oz.)
Recalling firmGlaxosmithkline Consumer Healthcare Holdings
DistributionProduct was distributed throughout the United States, including Puerto Rico.
Quantity151,056 bottles
Recall initiated2020-03-16
Report date2020-04-01
Recall completed2021-10-28
Recall numberD-1067-2020
ClassificationClass II
FDA statusTerminated
Origin on fileWarren NJ 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.