FDA Drug recall D-0337-2026
vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 020…
- FDA Drug
- Class II
- ongoing
- Published 2026-02-18
On 2026-02-18 the FDA classified a Class II recall of vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 020… by Fresenius Kabi Compounding, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0337-2026 |
| 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
vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lot # C274-000047611, Exp Date: 10-Feb-26; Lot # C274-000049633, Exp Date: 12-May-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-0337-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.