Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Details
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.
Recalling company
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Classification
Class III
Status
Terminated
Type
Voluntary: Firm initiated
Distribution
Nationwide in the USA
Initiated
Mar 4, 2025
FDA report date
Apr 9, 2025
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.