FDA Class III Recall: Tolterodine Tartrate ER Capsules by Major Pharmaceuticals

A nationwide recall has been initiated for Tolterodine Tartrate Extended-Release Capsules, 2 mg, packaged in 30-count unit dose cartons (NDC 0904-6592-04), and distributed by Major Pharmaceuticals of Indianapolis, IN. The affected product, identified under Lot#T05393 with an expiration date of September 30, 2025, failed to meet dissolution specifications during routine stability testing, prompting the voluntary recall. A total of 224 cartons are subject to this action, with distribution limited to the US.

The recall, classified as a Class III by the US Food and Drug Administration (FDA), indicates that use of the product is unlikely to cause adverse health consequences. The recall was initiated voluntarily by the manufacturer, The Harvard Drug Group LLC, doing business as Major Pharmaceuticals and Rugby Laboratories, located in La Vergne, Tennessee. Notification to consignees was issued via formal letter, and the recall remains ongoing as of the most recent update.

Tolterodine Tartrate is a prescription medication used to treat symptoms of an overactive bladder, such as urinary frequency, urgency, and incontinence. As an antimuscarinic agent, it works by relaxing bladder muscles to help improve bladder control. While no adverse events have been reported to date, pharmacists are advised to check inventory and quarantine affected product from Lot#T05393 to ensure patient safety and compliance.