Alteplase recalls

The FDA has published 4 recalls involving Alteplase since 2012. The latest was reported on 5 Jun 2024. Most were for sterility. CMC Enterprise Pharmacy has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls4since 2012

Last 12 months0reported

Class I00% of total

Ongoing0latest 5 Jun 2024

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 4 100%Class III 0 0%

Why alteplase is recalled

Sterility375%
Manufacturing (CGMP) Deviations125%

Companies

CMC Enterprise Pharmacy125%
Franck's Lab Inc., d.b.a. Franck's Compounding Lab125%
Genentech125%
Cardinal Health125%

By year

2024125%
2021125%
2019125%
2012125%

All alteplase recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
5 Jun 2024Drug	CLASS II	Cathflo activase (Alteplase), 2mg vials recalled by GenentechCathflo Activase	Genentech	Sterility	Nationwide
2 Jun 2021Drug	CLASS II	cathflo activase (Alteplase) 2 mg recalled by Cardinal HealthCathflo Activase	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
1 May 2019Drug	CLASS II	Alteplase 1 mg/mL in syringe, Made by: Enterprise Pharmacy recalled	CMC Enterprise Pharmacy	Sterility	NC
22 Aug 2012Drug	CLASS II	Alteplase, Sdpf - Syringe, 1/2") 1000mcg/ML Injectable recalled	Franck's Lab Inc., d.b.a. Franck's Compounding Lab	Sterility	Nationwide

Should you stop taking Alteplase?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.