Fentanyl Transdermal System recalls
The FDA has published 4 recalls involving Fentanyl Transdermal System since 2012. The latest was reported on 14 Feb 2018. Most were for potency & assay. Teva Pharmaceuticals USA 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 recalls4since 2012
Last 12 months0reported
Class I00% of total
Ongoing0latest 14 Feb 2018
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 1 25%Class III 3 75%
Why fentanyl transdermal system is recalled
Companies
By year
All fentanyl transdermal system recalls, newest first
4 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fentanyl Transdermal System, 50 mcg/h recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Fentanyl Transdermal System, 100 mcg/h recalled | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch recalled | Actavis | Potency & Assay | Nationwide |
| Drug | CLASS II | Fentanyl Transdermal System, 100 mcg/h recalled by Actavis | Actavis | Potency & Assay | Nationwide |
Should you stop taking Fentanyl Transdermal System?
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.