Why it was recalled
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot# T05393, Exp. Date: 09/30/2025
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0304-2025
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 4, 2025
- FDA report date
- Apr 9, 2025
- Quantity
- 224 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Original FDA data
Every field from FDA enforcement report D-0304-2025, exactly as published.
Show all FDA fields
- City
- La Vergne
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 96416
- Address
- 341 Mason Rd
- Code information
- Lot# T05393, Exp. Date: 09/30/2025
- Postal code
- 37086-3606
- Report date
- Apr 9, 2025
- Product type
- Drugs
- Recall number
- D-0304-2025
- Classification
- Class III
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Product quantity
- 224 cartons
- Termination date
- Feb 23, 2026
- Reason for recall
- Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 4, 2025
- Initial firm notification
- Letter
- Center classification date
- Mar 28, 2025