FDA Recall D-0139-2024

Padagis US LLC · Minneapolis, MN

Class II Ongoing 925 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

Lot / code: Lot: 231104, 231105, 231106, exp 7/31/2025

Quantity: 7,032 bottles

Reason for recall

Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules

Recall record

Recall number: D-0139-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2023-11-01
Classified by FDA Center: 2023-12-05
FDA published: 2023-12-13
Recalling firm: Padagis US LLC
Firm location: Minneapolis, MN

Drug identification

Brand name(s): TROSPIUM CHLORIDE
Generic name(s): TROSPIUM CHLORIDE
Manufacturer(s): Padagis US LLC
NDC(s): 0574-0118
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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