Tolterodine recalls
The FDA has published 4 recalls involving Tolterodine since 2014. The latest was reported on 9 Apr 2025. Most were for labeling errors. Aidapak Services 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 2014
Last 12 months0reported
Class I00% of total
Ongoing0latest 9 Apr 2025
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 2 50%Class III 2 50%
Why tolterodine is recalled
Companies
By year
All tolterodine recalls, newest first
4 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Tolterodine Tartrate Extended-Release Capsules, 2 mg Dose recalled | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS III | Tolterodine Tartrate Tablets, 1 mg recalled by Mylan Pharmaceuticals | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Tolterodine Tartrate ER, Capsule, 2 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Tolterodine Tartrate ER, Capsule, 4 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
Should you stop taking Tolterodine?
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.