Trospium Chloride Capsule, Extended Release
FDA Recall NDC 0574-0118
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Trospium Chloride (NDC 0574-0118). A significant event, classified as Class II, was initiated on Nov 01, 2023 by Padagis Us Llc. The reported reason for this action was: "Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
November 2023 Class II Recall: Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Recall Number
Class II Ongoing
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Nov 01, 2023
Dec 13, 2023
7,032 bottles
Recall Profile & Regulatory Data
Event ID
93345
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Padagis US LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun-248 197 Uttarakhand, India Distributed By: Padagis, Allegan, MI 49010. NDC: 0574-0118-30
Batch or Lot Expiration Information
Lot# Lot: 231104, 231105, 231106, exp 7/31/2025
Affected Packages Involved in this Recall
0574-0118-30Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
