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.

FDA recall notice · announced March 25, 2026 · Strides Pharma

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: U.S.A. Nationwide
Lot/code information: Lot: 7261973A, 7261974A, Exp 01/31/2027
Quantity: 89592 bottles
Status: Ongoing
Products in this recall event:
- 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. (D-0390-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.