Class I โ€” Serious Health Hazard

Serious health hazard โ€” there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use Recalled by Teva Pharmaceuticals USA Inc Due to Presence of Particulate Matter: Product was found to...

Date: March 29, 2022
Company: Teva Pharmaceuticals USA Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Teva Pharmaceuticals USA Inc directly.

Affected Products

IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc., North Wales, PA 19454, NDC 0703-4154-11.

Quantity: 1565 vials

Why Was This Recalled?

Presence of Particulate Matter: Product was found to contain silica and iron oxide

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Teva Pharmaceuticals USA Inc

Teva Pharmaceuticals USA Inc has 20 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report