Bendamustine HCl Injection (Baxter) – labeling issue (2023)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
Lots: 3A004A, 3A004B, Exp 12/31/2024, 3B005A, Exp 1/31/2025
Products Sold
Lots: 3A004A, 3A004B, Exp 12/31/2024; 3B005A, Exp 1/31/2025
Baxter Healthcare Corporation is recalling Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured due to Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026