Tolterodine Tartrate Extended-Release Capsules Recalled for Failed Dissolution
Tolterodine Tartrate Extended-Release Capsules, 2 mg (Lot T05393) are being recalled because they failed dissolution specifications. The capsules may not dissolve as intended.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall of a prescription medication with no reported illnesses, injuries, or deaths. While a dissolution failure poses a theoretical risk of reduced drug efficacy, the defect was discovered during routine testing before any patient harm occurred.
Plain-English summary
Major Pharmaceuticals is recalling Tolterodine Tartrate Extended-Release Capsules, 2 mg (Lot T05393, expiration 09/30/2025). The recall affects 224 cartons that were distributed nationwide in the United States.
The recall was issued because the capsules failed dissolution specifications discovered during routine stability testing. Dissolution is critical for extended-release medications—if capsules do not dissolve properly, the medication may not be released into the bloodstream as intended.
Tolterodine tartrate is a prescription medication used to treat symptoms of overactive bladder. Patients currently taking this medication from the affected lot should contact their pharmacist or healthcare provider to discuss next steps. Patients should not stop taking their medication without medical guidance.
The recalled product
- 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.
- Category
- Drug
- Hazard
- Affected units
- 224
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# T05393
- Exp. Date: 09/30/2025
Distribution
Distributed nationwide across the United States.
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