Class III โ€” Low Risk

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

Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection Recalled by Hikma Injectables USA Inc Due to Labeling: Wrong Barcode

Date: April 30, 2024
Company: Hikma Injectables USA Inc
Status: Completed
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 Injectables USA Inc directly.

Affected Products

Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05

Quantity: 1,895 bags

Why Was This Recalled?

Labeling: Wrong Barcode

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Hikma Injectables USA Inc

Hikma Injectables USA Inc has 4 total recalls tracked by RecallDetector.

Related Recalls

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