vancomycin HCl — Class II drug recall D-0336-2026
Ongoing recall by Fresenius Kabi Compounding, LLC, reported 2026-02-18, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0336-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi Compounding, LLC, Canton, MA, United States |
| Recall initiated | 2026-02-05 |
| Classified | 2026-02-13 |
| Reported by FDA | 2026-02-18 |
| Distributed | Nationwide (US) |
| Quantity | 1,578 bags |
| Reason classes | sterility |
| NDC | 71506-0016-59 |
| Lot numbers | C274-000049628 |
| Expiration dates | 2026-05-03 |
Product
vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59
Reason for recall
Lack of Assurance of Sterility
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0336-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.