Tolterodine Tartrate Tablets — Class III drug recall D-1539-2014
Terminated recall by Mylan Pharmaceuticals Inc., reported 2014-08-27, distributed nationwide. Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.
| Recall number | D-1539-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2014-06-20 |
| Classified | 2014-08-18 |
| Reported by FDA | 2014-08-27 |
| Terminated | 2015-10-09 |
| Distributed | Nationwide (US) |
| Quantity | 9,225 bottles |
| Reason classes | specification failure |
| NDC | 00378-5445-91 |
| Lot numbers | 2004069, 2004070 |
| Expiration dates | 2014-09 |
Product
Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.
Reason for recall
Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1539-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.