FDA Recalls Trospium Chloride Extended-Release Capsules for Manufacturing Defect
Padagis US LLC is recalling Trospium Chloride Extended-Release Capsules (60 mg) due to manufacturing defects where some capsules contain missing, broken, or extra tablets. The recall affects 7,032 bottles distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a prescription medication with a manufacturing defect that could affect drug dosing. No illnesses or injuries have been reported in the source text, placing this at the High severity level rather than Severe.
Plain-English summary
Padagis US LLC is recalling Trospium Chloride Extended-Release Capsules, 60 mg (NDC 0574-0118-30), manufactured by Sidmak Laboratories in India and distributed by Padagis in Allegan, Michigan. The recall encompasses 7,032 bottles with lot numbers 231104, 231105, and 231106, expiring July 31, 2025.
The capsules were found to have manufacturing defects, specifically missing, broken, or extra tablets within the capsule shells. These defects could compromise the intended drug delivery and patient dosing.
The affected product was distributed nationwide in the United States. Patients currently taking this medication should contact their pharmacist or healthcare provider immediately to discuss their treatment.
Consumers should not use the product and should contact their pharmacy to return it. Patients should speak with their healthcare provider about alternative treatment options. For additional information, patients may contact the FDA or their healthcare provider.
The recalled product
- Product
- TROSPIUM CHLORIDE (TROSPIUM CHLORIDE)
- Brand
- TROSPIUM CHLORIDE
- Manufacturer
- Padagis US LLC
- Category
- Drug — Prescription Medication
- Affected units
- 7,032
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 (4)
- Lot: 231104
- 231105
- 231106
- exp 7/31/2025
Distribution
Distributed nationwide across the United States.
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