Recalls / Class III
Class IIID-0304-2025
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.
- Brand name
- Tolterodine Tartrate
- Generic name
- Tolterodine
- Active ingredient
- Tolterodine Tartrate
- Route
- Oral
- NDCs
- 0904-6593, 0904-6592
- FDA application
- ANDA203016
- Affected lot / code info
- Lot# T05393, Exp. Date: 09/30/2025
Why it was recalled
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Recalling firm
- Firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Manufacturer
- Major Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 341 Mason Rd, La Vergne, Tennessee 37086-3606
Distribution
- Quantity
- 224 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-03-04
- FDA classified
- 2025-03-28
- Posted by FDA
- 2025-04-09
- Terminated
- 2026-02-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0304-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.