Reported Jun 5, 2024 · Terminated

Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64

Genentech, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Genentech, Inc. · 1 Dna Way Bldg 5 · South San Francisco, CA · 94080-4918

Is this the product you have?

  • Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Lot codes and dates
    • Lot #: 3618858
    • 3618873
    • Exp. Date 01/31/2026
Amount recalled
Lot:3618858 = 105,759; Lot:3618873 =90,359

Where it was sold

  • Nationwide

Why it was recalled

Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Genentech, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Aug 11, 2025 · Data as of Sep 19, 8:06 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.