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High risk Drugs & MedicationsClass II

Fresenius Kabi Ketamine HCl Recall

Ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02

Updated February 5, 2026

Fresenius Kabi is recalling ketamine HCl injections due to lack of assurance of sterility. Non-sterile injectable drugs can cause serious infections.

Is the Fresenius Kabi Compounding, LLC recalled? Yes. This product was recalled by FDA on February 5, 2026. Details below.

What is recalled

Ketamine HCl, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, NDC 71506-050-56, manufactured by Fagron Sterile Services, 20 Dan Road, Canton, MA 02021.

Am I affected

You're affected if you have received or are using this ketamine HCl injection with NDC 71506-050-56 from Fresenius Kabi Compounding.

What to do right now

Stop using this injection immediately. Contact your healthcare provider or hospital pharmacy right away to report that you may have received a non-sterile product and to discuss any necessary medical steps.

The hazard

Lack of Assurance of Sterility

Brands affected

Fresenius Kabi Compounding, LLC
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0334-2026
Classification
Class II
Recalled
February 5, 2026
Read the official notice

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