Recall: D-0390-2026

Class II - Potentially Harmful

Class IIClassification

2026-03-02Initiated

OngoingStatus

STRIDES PHARMA INCFirm

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

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

Distribution

U.S.A. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.