FDA recall D-0334-2026

Fresenius Kabi Compounding, LLC · Class II · drug

Product

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

Reason for recall

Lack of Assurance of Sterility

Distribution

US Nationwide.

Key facts

Status
Ongoing
Initiation date
2026-02-05
Report date
2026-02-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Canton, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0334-2026