FDA Drugs recall ·
Tolterodine Tartrate Extended-Release Capsules, 2 mg… recall
- Recall number
- D-0304-2025
- Date
- (initiated March 4, 2025)
- Company / brand
- Major Pharmaceuticals and Rugby Laboratories
341 Mason Rd, La Vergne, TN, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Terminated
- Units affected
- 224 cartons
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot# T05393, Exp. Date: 09/30/2025
Distribution
Nationwide in the USA
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0304-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.