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Drug FDA Class III Terminated Failed specifications

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.

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories Published Apr 9, 2025

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 35/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.

Hazards

Failed Dissolution · primary

Affected products (1)

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.

TOLTERODINE TARTRATE · 224 cartons

NDC: 0904-6593, 0904-6592, 0904-6592-04, 0904-6593-04
Lot codes: T05393
Code info: Lot# T05393, Exp. Date: 09/30/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Mar 4, 2025
  2. Published
    Apr 9, 2025
  3. Terminated
    Feb 23, 2026
Recall number
D-0304-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.