CLASS III Drug recall · Reported 27 Aug 2014 · FDA Enforcement Report
Tolterodine Tartrate Tablets, 1 mg recalled by Mylan Pharmaceuticals
Mylan Pharmaceuticals is recalling Tolterodine Tartrate Tablets, 1 mg, distributed nationwide in the US. The recall was initiated on 20 Jun 2014 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1539-2014
- FDA event ID
- 68642
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Jun 2014
- FDA classified
- 18 Aug 2014
- Reported
- 27 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Bladder & Prostate Medication
Timeline
| 20 Jun 2014 | Recall initiated by company | |
| 18 Aug 2014 | Classified by FDA | +59 days |
| 27 Aug 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.
Which lots are affected?
Lot # 2004069, Expiry: 09/2014; Lot #: 2004070, Expiry: 09/2014.
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mylan Pharmaceuticals
All 84| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Acamprosate Calcium, Delayed-Release Tablets, 333 mg recalledAcamprosate Calcium | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
Other Tolterodine recalls
All 4| 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 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 |