CLASS II ONGOING Drug recall · Reported 13 Dec 2023 · FDA Enforcement Report
Trospium Chloride Extended-Release Capsules, 60 mg recalled
Padagis US is recalling Trospium Chloride Extended-Release Capsules, 60 mg per, distributed nationwide in the US. The recall was initiated on 1 Nov 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0139-2024
- FDA event ID
- 93345
- Recalling firm
- Padagis US, Minneapolis, MN
- Brand
- Trospium Chloride
- Manufacturer
- Padagis US LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Nov 2023
- FDA classified
- 5 Dec 2023
- Reported
- 13 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 1 Nov 2023 | Recall initiated by company | |
| 5 Dec 2023 | Classified by FDA | +34 days |
| 13 Dec 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Trospium Chloride Extended-Release Capsules, 60 mg per recalled?
Yes. Padagis US recalled Trospium Chloride Extended-Release Capsules, 60 mg per on 1 Nov 2023. The recall is Class II and its status is Ongoing. Recall number D-0139-2024.
Why was it recalled?
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Which lots are affected?
Lot: 231104, 231105, 231106, exp 7/31/2025
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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