Cisplatin recalls

The FDA has published 4 recalls involving Cisplatin since 2012. The latest was reported on 23 Oct 2024. Most were for sterility. Infusion Options 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 23 Oct 2024

Recalls per month, last 24 months

click a bar for that month

1Oct '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 cisplatin is recalled

Sterility375%
Potency & Assay125%

Companies

By year

2024125%
2019250%
2012125%

All cisplatin recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
23 Oct 2024Drug	CLASS II	Cisplatin Injection, 100mg/ (1mg/mL) recalled by Accord HealthcareCisplatin	Accord Healthcare	Potency & Assay	Nationwide
21 Aug 2019Drug	CLASS II	Cisplatin 40 MG / NS Ivpb With Mannitol recalled by Infusion Options	Infusion Options	Sterility	NY
21 Aug 2019Drug	CLASS II	Cisplatin 40 MG / NS Ivpb With Mannitol recalled by Infusion Options	Infusion Options	Sterility	NY
22 Aug 2012Drug	CLASS II	Cisplatin 1mg/ML Injectable (2 Different Products) recalled	Franck's Lab Inc., d.b.a. Franck's Compounding Lab	Sterility	Nationwide

Should you stop taking Cisplatin?

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.