Leflunomide recalls
The FDA has published 3 recalls involving Leflunomide since 2012. The latest was reported on 22 Jan 2014. Most were for potency & assay. Apotex 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 recalls3since 2012
Last 12 months0reported
Class I00% of total
Ongoing0latest 22 Jan 2014
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 3 100%Class III 0 0%
Why leflunomide is recalled
Companies
By year
All leflunomide recalls, newest first
3 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Leflunomide Tablet, 10 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Leflunomide tablets, 20 mg recalled by ApotexLeflunomide | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Leflunomide tablets, 10 mg, a) bottle recalled by ApotexLeflunomide | Apotex | Potency & Assay | Nationwide |
Should you stop taking Leflunomide?
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.