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Drug FDA Class II Ongoing Foreign material

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.

STRIDES PHARMA INC Published Mar 25, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact STRIDES PHARMA INC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Black Particles and Gel-like Mass · primary

Affected products (1)

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.

IBUPROFEN · 89592 bottles

NDC: 51672-5321, 51672-5321-8, 51672-5321-1
Lot codes: 7261973A
Code info: Lot: 7261973A, 7261974A, Exp 01/31/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Mar 2, 2026
  2. Published
    Mar 25, 2026
Recall number
D-0390-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.