Orphenadrine recalls
The FDA has published 3 recalls involving Orphenadrine since 2014. The latest was reported on 13 Apr 2022. Most were for labeling errors. Sandoz 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 2014
Last 12 months0reported
Class I00% of total
Ongoing0latest 13 Apr 2022
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 2 67%Class III 1 33%
Why orphenadrine is recalled
Companies
By year
All orphenadrine recalls, newest first
3 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Orphenadrine Citrate Extended-Release Tablets, USP 100 mg recalledOrphenadrine Citrate | Sandoz | Nitrosamine Impurity | Nationwide |
| Drug | CLASS III | Orphenadrine Citrate Extended Release Tablets, 100 mg a) recalledOrphenadrine Citrate | Sandoz | Potency & Assay | Nationwide |
| Drug | CLASS II | Orphenadrine Citrate ER Tablet, 100 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
Should you stop taking Orphenadrine?
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.