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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Bendamustine HCl Injection Recalled for Missing or Peeling Labels

Agency Publication Date: August 24, 2023
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Summary

Baxter Healthcare Corporation has recalled 13,502 vials of Bendamustine HCl Injection, 100mg/4mL (25mg/mL), a prescription chemotherapy medication. The recall was issued because the labels on some vials were found to be partially or completely peeling off, which could make it impossible to identify the drug. These vials were distributed nationwide across the United States to hospitals, clinics, and pharmacies.

Risk

If the label is missing or peeling, healthcare providers cannot verify the medication name, strength, or expiration date before use. This poses a risk of medication errors, potentially leading to the administration of the wrong drug or an incorrect dosage. No injuries or incidents have been reported to date.

What You Should Do

  1. This recall affects Bendamustine HCl Injection, 100mg/4mL (25mg/mL), sold in 4 mL multiple-dose vials with NDC 10019-079-01.
  2. Check your inventory for lot numbers 3A004A and 3A004B (with expiration date 12/31/2024) or lot number 3B005A (with expiration date 1/31/2025).
  3. Stop using the recalled product. Contact Baxter Healthcare Corporation or your distributor to arrange return.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Bendamustine HCl Injection (100mg/4mL)
Variants: 25mg/mL, One 4 mL Multiple-Dose Vial, Rx only
Lot Numbers:
3A004A (Exp 12/31/2024)
3A004B (Exp 12/31/2024)
3B005A (Exp 1/31/2025)
NDC:
10019-079-01

Recall #: D-1103-2023. Total quantity affected: 13,502 vials.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92887
Status: Resolved
Manufacturer: Baxter Healthcare Corporation
Sold By: hospitals; clinics; pharmacies
Manufactured In: United States
Units Affected: 13,502 vials
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.