Vancomycin Injection — Class II drug recall D-0805-2026
Ongoing recall by Baxter Healthcare Corporation, reported 2026-09-09, distributed nationwide. CGMP Deviations
| Recall number | D-0805-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2026-08-06 |
| Classified | 2026-08-28 |
| Reported by FDA | 2026-09-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL |
| Reason classes | cgmp |
| NDC | 00338-0122, 00338-0122-04, 00338-0124, 00338-0124-04, 00338-3551, 00338-3551-48, 00338-3552, 00338-3552-48, 00338-3580, 00338-3580-48, 00338-3581, 00338-3581-01, 00338-3582, 00338-3582-01, 00338-3583, 00338-3583-01 |
| Lot numbers | NC188678, NC188814, NC188944, NC193610, NC193665 |
| Expiration dates | 2026-12-01, 2026-12-05, 2026-12-08, 2027-04-21, 2027-04-23 |
Product
Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3552-48.
Reason for recall
CGMP Deviations
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-0805-2026. 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.