Fresenius Kabi Compounding, Llc: Ketamine Hcl, 1,000 Mg, 1,000 Mg Per
Recall Summary Fresenius Kabi Compounding is recalling ketamine HCl injections (1,000 mg per 100 mL vials, NDC 71506-050-56) distributed nationwide because sterility cannot be assured. This is a serious Class I recall affecting a compounded injectable drug that was distributed across all U.S. states and Washington D.C.
- Recalling firm
- Fresenius Kabi Compounding, LLC
- 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
- Lack of Assurance of Sterility
- Classification
- Class I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-02-05
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/f8b3426f-cbd0-4950-b0be-ab3b341e5374