Tolterodine Tartrate Extended-Release Capsules recall: Failed Dissolution
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 Tolterodine Tartrate Extended-Release Capsules recalled?
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot# T05393, Exp. Date: 09/30/2025
- 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.
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Quantity
- 224 cartons
- Distribution
- Nationwide in the USA
- Recall date
- April 9, 2025
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)