FDAClass IIDecember 13, 2023

Trospium Chloride Extended-Release Capsules recall

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

Why was Trospium Chloride Extended-Release Capsules recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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
Recalling firm
Padagis US LLC
Quantity
7,032 bottles
Distribution
Nationwide in the USA
Recall date
December 13, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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