FDA Drug recall D-0139-2024
Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories (India) Pvt
- FDA Drug
- Class II
- ongoing
- Published 2023-12-13
On 2023-12-13 the FDA classified a Class II recall of Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories (India) Pvt by Padagis Us, citing failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0139-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-01 |
| Published | 2023-12-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Padagis Us |
| Distribution | US |
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
Reason
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Identifiers
| ndc | 0574-0118-30 |
|---|---|
| code_info | Lot: 231104, 231105, 231106, exp 7/31/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0139-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.