Tolterodine Tartrate Extended-Release Capsules recall
FDA recall D-0304-2025 · initiated Mar 4, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled Tolterodine Tartrate Extended-Release Capsules in Mar 2025 — an FDA Class III recall (D-0304-2025) because Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 224 cartons
Details
- 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 company
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Classification
- Class III
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Mar 4, 2025
- FDA report date
- Apr 9, 2025
Frequently asked
- Was Tolterodine Tartrate Extended-Release Capsules recalled?
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled Tolterodine Tartrate Extended-Release Capsules in Mar 2025 — an FDA Class III recall (D-0304-2025) because Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Tolterodine Tartrate Extended-Release Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0304-2025 was: Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
- Is a recalled Tolterodine Tartrate Extended-Release Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Tolterodine Tartrate Extended-Release Capsules are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot# T05393, Exp. Date: 09/30/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0304-2025.