Cathflo activase (ALTEPLASE) recall
FDA recall D-0509-2024 · initiated May 20, 2024
Genentech, Inc. recalled Cathflo activase (ALTEPLASE) in May 2024 — an FDA Class II recall (D-0509-2024) because Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: Lot:3618858 = 105,759; Lot:3618873 =90,359
Details
- Product
- Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
- Recalling company
- Genentech Inc
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- May 20, 2024
- FDA report date
- Jun 5, 2024
This recall is linked to a product we cover: Cathflo Activase →
Frequently asked
- Was Cathflo activase (ALTEPLASE) recalled?
- Genentech, Inc. recalled Cathflo activase (ALTEPLASE) in May 2024 — an FDA Class II recall (D-0509-2024) because Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Cathflo activase (ALTEPLASE) recalled?
- Per the FDA enforcement record, the reason for recall D-0509-2024 was: Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
- Is a recalled Cathflo activase (ALTEPLASE) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Cathflo activase (ALTEPLASE) are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: 3618858, 3618873, Exp. Date 01/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0509-2024.