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Class II · ModerateRecall completed

Ibuprofen

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

Does this affect you?
Check your lot numberLot #: J871033187, Exp 9/20
Where it was soldU.S.A. Nationwide
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

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

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 bySun Pharmaceutical Industries, Inc.
Brand nameIBUPROFEN
Generic nameIBUPROFEN
Active ingredient(s)IBUPROFEN
Distributed by / forTaro Pharmaceuticals, U.S.A., Inc., Hawthorne, NY 10532
NDC51672-2130-1
Show the full FDA record
Full product labelChildren's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL), Distributed by: Taro Pharmaceuticals, U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-1
Recalling firmTaro Pharmaceuticals U.S.A., Inc.
DistributionU.S.A. Nationwide
Quantity5,190 bottles
Recall initiated2019-09-27
Report date2019-11-06
Recall completed2023-08-31
Recall numberD-0301-2020
ClassificationClass II
FDA statusTerminated
Origin on fileHawthorne NY United States

Related

Ibuprofen recallsRecent drug recallsCheck another medication

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.