Asenapine recalls
The FDA has published 3 recalls involving Asenapine since 2017. The latest was reported on 26 May 2021. Most were for packaging defects. SigmaPharm Laboratories 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 2017
Last 12 months0reported
Class I00% of total
Ongoing0latest 26 May 2021
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 1 33%Class III 2 67%
Why asenapine is recalled
Companies
Brands
By year
All asenapine recalls, newest first
3 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Asenapine Sublingual Tablets, 10 mg recalled by SigmaPharm LaboratoriesAsenapine | SigmaPharm Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS III | Asenapine Sublingual Tablets, 5 mg recalled by SigmaPharm LaboratoriesAsenapine | SigmaPharm Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS II | Saphris 10 mg (asenapine) sublingual tablets, count recalledSaphris | Forest Laboratories | Packaging Defects | Nationwide |
Should you stop taking Asenapine?
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.