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.

FDA recall notice · announced April 9, 2025 · The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot# T05393, Exp. Date: 09/30/2025
Quantity: 224 cartons
Status: Terminated
Products in this recall event:
- 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. (D-0304-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.