# FDA recall D-0304-2025

> **The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories** · Class III · drug recall initiated 2025-03-04.

## 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.

## Reason for recall

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

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0304-2025
- **Recalling firm:** The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2025-03-04
- **Report date:** 2025-04-09
- **Termination date:** 2026-02-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** La Vergne, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0304-2025

## Citation

> AI Analytics. FDA recall D-0304-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0304-2025. Source: US FDA. Licensed CC0.

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