Class III

Drug Recall: 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 · March 4, 2025

Reason for Recall

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

Distribution

Nationwide in the USA

States Affected

NATIONWIDE

Quantity Affected

224 cartons

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0304-2025

Status: terminated

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories Drug Recall: 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. | SafeCheck