Cysteamine recalls

The FDA has published 3 recalls involving Cysteamine since 2018. The latest was reported on 21 Oct 2020. Most were for potency & assay. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls3since 2018

Last 12 months0reported

Class I00% of total

Ongoing0latest 21 Oct 2020

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 0 0%Class III 3 100%

Why cysteamine is recalled

Potency & Assay267%
Sterility133%

Companies

Leadiant Biosciences3100%

By year

2020133%
2018267%

All cysteamine recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
21 Oct 2020Drug	CLASS III	Cystaran (cysteamine ophthalmic solution) recalledCystaran	Leadiant Biosciences	Sterility	PA
25 Apr 2018Drug	CLASS III	Cystaran (cysteamine ophthalmic solution) recalledCystaran	Leadiant Biosciences	Potency & Assay	PA
7 Mar 2018Drug	CLASS III	Cystaran (cysteamine ophthalmic solution) recalledCystaran	Leadiant Biosciences	Potency & Assay	PA

Should you stop taking Cysteamine?

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.