Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Bleomycin for Injection Recalled by Hikma Pharmaceuticals USA Inc. Due to Mislabeling

Date: August 5, 2021
Company: Hikma 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 Hikma Pharmaceuticals USA Inc. directly.

Affected Products

Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GmbH Schiffgraben 23, 38690 Gosfar, Germany Distributed by Hikma USA Inc. Berkeley Heights, NJ 07922, NDC 0143-9240-01

Quantity: 1,152 vials

Why Was This Recalled?

Labeling: Not elsewhere classified: Mislabeling

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Hikma Pharmaceuticals USA Inc.

Hikma Pharmaceuticals USA Inc. has 18 total recalls tracked by RecallDetector.

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