Children's Ibuprofen Oral Suspension USP

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

Cause type: Particulate / foreign matter

Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.

What was recalled

Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL), Distributed by: Taro Pharmaceuticals, U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-1

Affected NDC 51672-2130-01

Compare with the code on your package — it is the most precise check available.

Drug: Alcohol Category: Pain Relief & OTC Medication

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

Product	Strength	Form & route	Labeler	Type
Ibuprofen NDC 51672-2130	100 mg/5mL	Suspension Oral	Sun Pharmaceutical Industries, Inc.	OTC

Recalling firm: Taro Pharmaceuticals U.S.A., Inc.
NDC code: 51672-2130-1
Origin: NY, United States
Initiated by: Voluntary: Firm initiated
FDA recall number: D-0301-2020 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.