FDAFDA · Food and drugs·Recall number D-0304-2025
Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6592-04.
Published April 9, 2025 · Recall initiated: March 4, 2025
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Distributor
- Nationwide in the USA
- Lot
- Lot# T05393, Exp. Date: 09/30/2025
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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