Reported Apr 9, 2025 · Terminated
Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and…
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · 341 Mason Rd · La Vergne, TN · 37086-3606
Is this the product you have?
- Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only
- Packaged and Distributed byMajor Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6592-04
- Lot codes and dates
- Lot# T05393, Exp
- Date09/30/2025
- Amount recalled
- 224 cartons
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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