FDA-Drug2026-03-25Class IIPROCESSING DEFECT

Strides Pharma Children's Ibuprofen Oral Suspension recalled for foreign particles

OTHERNationwide distributionDrugsBaby & kids

What this means

Strides Pharma Children's Ibuprofen Oral Suspension (100 mg per 5 mL) has been recalled because some bottles contain gel-like masses and black particles. The affected bottles are 4 FL OZ (120 mL) size with lot numbers 7261973A or 7261974A, expiring 01/31/2027. No injuries have been reported.

  • Check if you have a bottle with lot number 7261973A or 7261974A
  • Do not give this medication to your child
  • Contact your pharmacist or doctor about a safe alternative pain reliever
  • Dispose of the bottle safely
The agency's original wording
Hazard

Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.

Intended for
Children (under 12 years)
Illnesses reported
None reported
Sold states
U.S.A. Nationwide
Affected count
89592 bottles
Manufactured in
200 Crossing Blvd Ste 110, N/A, Bridgewater, NJ, United States
Products
Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0390-2026

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