Why it was recalled
Lack of Assurance of Sterility
Product description
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0334-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 5, 2026
- FDA report date
- Feb 18, 2026
- Quantity
- 1410 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi Compounding, LLC
Original FDA data
Every field from FDA enforcement report D-0334-2026, exactly as published.
Show all FDA fields
- City
- Canton
- State
- MA
- Status
- Ongoing
- Country
- United States
- Event ID
- 98391
- Address
- 20 Dan Rd
- Code information
- 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
- Postal code
- 02021-2809
- Report date
- Feb 18, 2026
- Product type
- Drugs
- Recall number
- D-0334-2026
- Classification
- Class II
- Recalling firm
- Fresenius Kabi Compounding, LLC
- Product quantity
- 1410 bags
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Feb 5, 2026
- Initial firm notification
- Letter
- Center classification date
- Feb 13, 2026