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.

GENTAMICIN INJECTION Recalled by Fresenius Kabi USA, LLC Due to Defective Container: Vials may be missing stoppers.

Date: November 12, 2014
Company: Fresenius Kabi USA, LLC
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 Fresenius Kabi USA, LLC directly.

Affected Products

GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-010-20

Quantity: 92,125 vials

Why Was This Recalled?

Defective Container: Vials may be missing stoppers.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Fresenius Kabi USA, LLC

Fresenius Kabi USA, LLC has 67 total recalls tracked by RecallDetector.

Related Recalls

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