Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Irinotecan HCL Injection Recalled by Hikma Pharmaceuticals USA Inc. Due to Defective Container: Customer complaints received of a crimp...

Date: June 11, 2020
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

Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9583-01

Quantity: 17,998 vials

Why Was This Recalled?

Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.

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.

Related Recalls

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