FDA recall D-0390-2026

Product

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.

Reason for recall

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

Distribution

U.S.A. Nationwide

Key facts

Status

Ongoing

Initiation date

2026-03-02

Report date

2026-03-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bridgewater, NJ, United States

Primary source

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