FDA Drug recall D-0334-2026
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 0…
- FDA Drug
- Class II
- ongoing
- Published 2026-02-18
On 2026-02-18 the FDA classified a Class II recall of 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 0… by Fresenius Kabi Compounding, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0334-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-05 |
| Published | 2026-02-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fresenius Kabi Compounding |
| Distribution | US |
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
Identifiers
| code_info | Lot # C274-000047883, Exp Date: 17-Feb-26; Lot # C274-000048515, Exp Date: 22-Mar-26; Lot # C274-000048679, Exp Date: 3…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0334-2026%22
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