D-0304-2025 Class III Terminated
FDA drug recall D-0304-2025 was initiated by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories on March 4, 2025 and is designated Class III. Reason for recall: Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution. The recall status is terminated (terminated February 23, 2026). Affected quantity: 224 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- April 9, 2025
- Initiation Date
- March 4, 2025
- Termination Date
- February 23, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 224 cartons
Product Description
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.
Reason for Recall
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Distribution Pattern
Nationwide in the USA
Code Information
Lot# T05393, Exp. Date: 09/30/2025