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Stop using now Drug recall · FDA · Published May 20, 2024

Genentech Cathflo Activase 2mg Vials Recall: Deformed Stoppers Risk Contamination

Genentech recalls 2mg Cathflo Activase vials with deformed stoppers that may cause contamination. Affected lots expire 01/31/2026. Stop using immediately to avoid infection risks.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0509-2024DrugGenentech ›
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Contact the company

Recalling firmGenentech, Inc.1 Dna Way Bldg 5 · South San Francisco, CA 94080-4918
✎ GovInfoNow plain-language explainer

Genentech is recalling 2mg Cathflo Activase vials that have deformed stoppers during manufacturing. This could lead to contamination if the vial is used, posing a risk of infection. Affected vials have specific lot numbers and expire by January 31, 2026. Read more at govinfonow.com/recall/32659-genentech-cathflo-activase-2mg-vials-recall-deformed-stoppers-risk-contamination.

Source Summary by GovInfoNow · govinfonow.com/recall/32659-genentech-cathflo-activase-2mg-vials-recall-deformed-stoppers-risk-contamination · Updated August 17, 2026 · FDA enforcement record: FDA #D-0509-2024

Cite this page

“Genentech Cathflo Activase 2mg Vials Recall: Deformed Stoppers Risk Contamination.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32659-genentech-cathflo-activase-2mg-vials-recall-deformed-stoppers-risk-contamination. Based on FDA recall #D-0509-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0509-2024%22&limit=1).

The FDA announced on May 20, 2024, that Genentech Inc. voluntarily recalled Cathflo activase (ALTEPLASE) 2mg vials due to a lack of assurance of sterility caused by deformed stoppers observed during filling operations.

How to tell if you have it

  • Brand: Genentech
  • Product: Cathflo activase (ALTEPLASE), 2mg vials, Rx only
  • NDC: 50242-041-64
  • Lot #: 3618858, 3618873
  • Exp. Date: 01/31/2026

The hazard

The recall addresses a lack of assurance of sterility resulting from deformed stoppers observed during filling operations for the affected vials.

Context

GovInfoNow's records show Genentech, Inc. has had 9 other recalls on record since July 30, 2012. Other recent recalls of similar products include Victory Medical Center Pharmacy Glutathione Vials Recall (July 1, 2026), Mallinckrodt Acthar Gel 5mL Vial Recall (Aug. 6, 2026), and Wells Pharma Fentanyl Citrate Injectable Solution Recall (April 1, 2026).

How to tell if you have this one

Check for vials labeled 'Cathflo Activase (ALTEPLASE), 2mg' with lot numbers 3618858 or 3618873. These vials expire by January 31, 2026, and were manufactured by Genentech in South San Francisco.

  • Brand
    Genentech
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Immediately

    Discard any vials with lot numbers 3618858 or 3618873 to prevent potential contamination.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 15 months after the firm started it.

1. Firm started the recall: May 20, 202412. FDA classified it Class II: May 24, 202423. Published in FDA’s Enforcement Report: Jun 5, 202434. FDA terminated the recall: Aug 11, 2025420242025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0509-2024 (May 20, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0509-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA