Fluorouracil recalls

The FDA has published 12 recalls involving Fluorouracil since 2012. The latest was reported on 21 Aug 2019. Most were for sterility. Lincare 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 recalls12since 2012

Last 12 months0reported

Class I18% of total

Ongoing0latest 21 Aug 2019

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0 0Dec 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0

Severity split

Class I 1 8%Class II 11 92%Class III 0 0%

Why fluorouracil is recalled

Companies

By year

2019325%
2015867%
201218%

All fluorouracil recalls, newest first

12 total

Reported	Class	Recall	Company	Reason	Where
21 Aug 2019Drug	CLASS II	Fluorouracil 560 MG / IVP recalled by Infusion Options	Infusion Options	Sterility	NY
21 Aug 2019Drug	CLASS II	Fluorouracil 560 MG / IVP Fluorouracil 3340 MG QS 0.9% NACL recalled	Infusion Options	Sterility	NY
24 Jul 2019Drug	CLASS I	Fluorouracil Injection, USP (50 mg / mL) fill in a vial recalledFluorouracil	Fresenius Kabi USA	Particulate Matter	Nationwide
8 Jul 2015Drug	CLASS II	Fluorouracil 4250mg / D5W, Qty recalled by Lincare	Lincare	Sterility	AR
8 Jul 2015Drug	CLASS II	Fluorouracil 4600mg / D5W, Qty recalled by Lincare	Lincare	Sterility	AR
8 Jul 2015Drug	CLASS II	Fluorouracil 5760mg / D5W Qty recalled by Lincare	Lincare	Sterility	AR
8 Jul 2015Drug	CLASS II	Fluorouracil 3200mg / D5W, Qty recalled by Lincare	Lincare	Sterility	AR
8 Jul 2015Drug	CLASS II	Fluorouracil 1560MG / D5W, Qty recalled by Lincare	Lincare	Sterility	AR
8 Jul 2015Drug	CLASS II	Fluorouracil 4800mg / D5W, Qty recalled by Lincare	Lincare	Sterility	AR
8 Jul 2015Drug	CLASS II	Fluorouracil 1200mg / D5W, Qty recalled by Lincare	Lincare	Sterility	AR
8 Jul 2015Drug	CLASS II	Fluorouracil 1400mg / D5W Qty recalled by Lincare	Lincare	Sterility	AR
12 Dec 2012Drug	CLASS II	Fluorouracil Topical Cream USP, 5% Tube recalledFluorouracil	Taro Pharmaceuticals U	Potency & Assay	Nationwide

Should you stop taking Fluorouracil?

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.