Ketamine HCl recalled over sterility concerns

Recall date

February 5, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Fresenius Kabi Compounding, LLC recalls ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Da…

Recall number

D-0334-2026

FDA classification

Class II

Brand / firm

Fresenius Kabi Compounding, LLC

Sold / distributed

US Nationwide.

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 02021, NDC 71506-050-56