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

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