Bendamustine HCl Injection — Class III drug recall D-1103-2023
Completed recall by Baxter Healthcare Corporation, reported 2023-08-30, distributed nationwide. Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injec
| Recall number | D-1103-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2023-08-14 |
| Classified | 2023-08-24 |
| Reported by FDA | 2023-08-30 |
| Distributed | Nationwide (US) |
| Quantity | 13,502 vials |
| Reason classes | labeling |
| NDC | 10019-0079, 10019-0079-01 |
| Lot numbers | 3A004A, 3A004B, 3B005A |
| Expiration dates | 2024-12-31, 2025-01-31 |
Product
Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01.
Reason for recall
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
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-1103-2023. 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.