Recalls / Class II
Class IID-0334-2026
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
- Affected lot / code info
- Lot # C274-000047883, Exp Date: 17-Feb-26; Lot # C274-000048515, Exp Date: 22-Mar-26; Lot # C274-000048679, Exp Date: 31-Mar-26; Lot # C274-000049119, Exp Date: 19-Apr-26; Lot # C274-000049282, Exp Date: 27-Apr-26
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Fresenius Kabi Compounding, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20 Dan Rd, N/A, Canton, Massachusetts 02021-2809
Distribution
- Quantity
- 1410 bags
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2026-02-05
- FDA classified
- 2026-02-13
- Posted by FDA
- 2026-02-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0334-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.