March 2025 FDA Recall Tolterodine Tartrate by The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories
D-0304-2025 - Failed Dissolution Specifications

This Class III drug recall was voluntarily initiated by The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories on March 4, 2025 for the product Tolterodine Tartrate. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0304-2025

Reason for Recall
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Initiated
03-04-2025
Reported
04-09-2025
Quantity
224 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96416
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-23-2026
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# T05393, Exp. Date: 09/30/2025

Affected Packages Involved in this Recall

0904-6592-04 Tolterodine Tartrate
0904-6593-04 Tolterodine Tartrate