Prescription Injection Recalled Due to Missing or Peeled Labels
Baxter Healthcare Corporation recalls Bendamustine Hydrochloride injection nationwide because labels are missing or partially peeled off vials, raising the risk of medication errors.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses, injuries, or medication errors. The hazard is a labeling defect (missing or peeled labels) with theoretical rather than documented risk. Per the severity rubric, Class III recalls are typically scored 1 or 2; without reported harm, this qualifies as Moderate (2).
Plain-English summary
Baxter Healthcare Corporation is recalling Bendamustine Hydrochloride (Bendamustine HCl) injection, 100mg/4mL, due to labeling defects where labels are partially or completely peeled off the injection vials. This defect was identified following customer complaints.
The recall affects 13,502 vials distributed nationwide in the United States. The affected lots are 3A004A and 3A004B (expiring 12/31/2024), and 3B005A (expiring 1/31/2025). The product carries NDC 10019-079-01 and is manufactured for Baxter Healthcare Corporation, Deerfield, Illinois.
Healthcare providers and patients should stop using affected vials immediately. Do not use vials with missing or peeled labels, as this makes it impossible to verify the medication, concentration, and lot information. Contact Baxter Healthcare Corporation or consult your healthcare provider if you have received or used product from the affected lots.
The recalled product
- Product
- BENDAMUSTINE HYDROCHLORIDE (BENDAMUSTINE HYDROCHLORIDE)
- Brand
- BENDAMUSTINE HYDROCHLORIDE
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — Injectable
- Hazard
- Affected units
- 13,502
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lots: 3A004A
- 3A004B
- Exp 12/31/2024
- 3B005A
- Exp 1/31/2025
Distribution
Distributed nationwide across the United States.
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