The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distr
Recalled April 9, 2025 · FDA recall D-0304-2025 · The Harvard Drug Group LLC
Hazard
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution. · FDA Class III
Units
224 cartons
Sold at
Nationwide in the USA
Description
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
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.
Manufacturer(s)
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →