Decitabine recalls

The FDA has published 2 recalls involving Decitabine since 2018. The latest was reported on 21 Aug 2019. Most were for potency & assay. 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 recalls2since 2018

Last 12 months0reported

Class I00% of total

Ongoing0latest 21 Aug 2019

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 1 50%Class III 1 50%

Why decitabine is recalled

Potency & Assay150%
Sterility150%

Companies

Infusion Options150%
InvaGen Pharmaceuticals150%

By year

2019150%
2018150%

All decitabine recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
21 Aug 2019Drug	CLASS II	Decitabine 40 MG / Ns Ivpb recalled by Infusion Options	Infusion Options	Sterility	NY
18 Apr 2018Drug	CLASS III	Decitabine for Injection, 50mg per vial recalled	InvaGen Pharmaceuticals	Potency & Assay	Nationwide

Should you stop taking Decitabine?

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.