FDA Drug recall D-1539-2014
Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only
- FDA Drug
- Class III
- terminated
- Published 2014-08-27
On 2014-08-27 the FDA classified a Class III recall of Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only by Mylan Pharmaceuticals, citing failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1539-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-06-20 |
| Published | 2014-08-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mylan Pharmaceuticals |
| Distribution | US |
Product
Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.
Reason
Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.
Identifiers
| code_info | Lot # 2004069, Expiry: 09/2014; Lot #: 2004070, Expiry: 09/2014. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1539-2014%22
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