Febuxostat recalls

The FDA has published 6 recalls involving Febuxostat since 2014. The latest was reported on 20 Mar 2024. 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 recalls6since 2014

Last 12 months0reported

Class I00% of total

Ongoing2latest 20 Mar 2024

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 6 100%Class III 0 0%

Why febuxostat is recalled

Companies

By year

2024583%
2014117%

Ongoing febuxostat recalls

2 active

Reported	Class	Recall	Company	Reason	Where
20 Mar 2024Drug	CLASS II	Febuxostat Tablets 40mg recalled by Sun Pharmaceutical IndustriesFebuxostat	SUN Pharmaceutical Industries	Sterility	Nationwide
20 Mar 2024Drug	CLASS II	Febuxostat Tablets 80mg recalled by Sun Pharmaceutical IndustriesFebuxostat	SUN Pharmaceutical Industries	Sterility	Nationwide

All febuxostat recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
20 Mar 2024Drug	CLASS II	Febuxostat Tablets 40mg recalled by Sun Pharmaceutical IndustriesFebuxostat	SUN Pharmaceutical Industries	Sterility	Nationwide
20 Mar 2024Drug	CLASS II	Febuxostat Tablets 80mg recalled by Sun Pharmaceutical IndustriesFebuxostat	SUN Pharmaceutical Industries	Sterility	Nationwide
14 Feb 2024Drug	CLASS II	Febuxostat Tablets, 40 mg (3 recalled by Amerisource Health ServicesFebuxostat	Amerisource Health Services	Manufacturing (CGMP) Deviations	Nationwide
31 Jan 2024Drug	CLASS II	Febuxostat Tablets 40mg recalled by Sun Pharmaceutical IndustriesFebuxostat	SUN Pharmaceutical Industries	Sterility	Nationwide
31 Jan 2024Drug	CLASS II	Febuxostat Tablets 80 mg recalled by Sun Pharmaceutical IndustriesFebuxostat	SUN Pharmaceutical Industries	Sterility	Nationwide
22 Jan 2014Drug	CLASS II	Febuxostat Tablet, 40 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

Should you stop taking Febuxostat?

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.