Tolterodine Tartrate (Major Pharmaceuticals) – Dissolution Failure (2025)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Lot Codes / Batch Numbers
Lot# T05393, Exp. Date: 09/30/2025
Products Sold
Lot# T05393, Exp. Date: 09/30/2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories is recalling Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only due to Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026