Doxorubicin recalls

The FDA has published 7 recalls involving Doxorubicin since 2012. The latest was reported on 17 Jun 2026. Most were for sterility. Sun Pharmaceutical Industries 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 recalls7since 2012

Last 12 months1reported

Class I114% of total

Ongoing1latest 17 Jun 2026

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 1 0 0Aug 0 0

Severity split

Class I 1 14%Class II 4 57%Class III 2 29%

Why doxorubicin is recalled

Companies

Sun Pharmaceutical Industries229%
Baxter Healthcare114%
Fresenius Kabi USA114%
Infusion Options114%
Mylan Institutional114%
Franck's Lab Inc., d.b.a. Franck's Compounding Lab114%

Brands

Doxorubicin Hydrochloride343%
Doxil114%

By year

2026114%
2023114%
2020114%
2019114%
2018114%
2015114%
2012114%

Ongoing doxorubicin recalls

1 active

Reported	Class	Recall	Company	Reason	Where
17 Jun 2026Drug	CLASS I	DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride	SUN Pharmaceutical Industries	Particulate Matter	Nationwide

All doxorubicin recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
17 Jun 2026Drug	CLASS I	DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride	SUN Pharmaceutical Industries	Particulate Matter	Nationwide
25 Oct 2023Drug	CLASS II	Doxil (doxorubicin hydrochloride liposome injection) 50 mg recalledDoxil	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide
2 Dec 2020Drug	CLASS III	DOXOrubicin Hydrochloride Injection, USP, 10 mg recalledDoxorubicin Hydrochloride	Fresenius Kabi USA	Other	Nationwide
21 Aug 2019Drug	CLASS II	Doxorubicin 110 MG / IVP Syringe recalled by Infusion Options	Infusion Options	Sterility	NY
31 Jan 2018Drug	CLASS II	DOXOrubicin Hydrochloride Liposome Injection, 20 mg recalledDoxorubicin Hydrochloride	Sun Pharmaceutical Industries	Sterility	Nationwide
25 Mar 2015Drug	CLASS III	DOXOrubicin Hydrochloride Injection, USP, 200 mg/ (2 mg/mL) recalled	Mylan Institutional	Packaging Defects	Nationwide
22 Aug 2012Drug	CLASS II	Doxorubicin HCL, Lyophilized 10mg Vial 2 Vial recalled	Franck's Lab Inc., d.b.a. Franck's Compounding Lab	Sterility	Nationwide

Should you stop taking Doxorubicin?

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.