FDA-Drug2026-02-18Class IIPROCESSING DEFECT
Fresenius Kabi ketamine HCl injection recalled for sterility assurance failure
What this means
Fresenius Kabi Compounding has recalled five specific lots of ketamine HCl injection (10 mg per mL) distributed nationwide because the manufacturer cannot confirm the product remains sterile. The affected lots were produced between February and April 2026.
- Check your facility's inventory for ketamine HCl injection from Fagron Sterile Services with lot numbers C274-000047883, C274-000048515, C274-000048679, C274-000049119, or C274-000049282.
- Do not use any product from these lots.
- Contact your supplier or Fresenius Kabi for instructions on return or disposal.
- Consult your healthcare provider if you have questions about alternative medications.
The agency's original wording
Hazard
Lack of Assurance of Sterility
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide.
Affected count
1410 bags
Manufactured in
20 Dan Rd, N/A, Canton, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0334-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.