FDA Drug recall D-0161-2023
Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by: Lannett Com…
- FDA Drug
- Class III
- terminated
- Published 2023-01-25
On 2023-01-25 the FDA classified a Class III recall of Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by: Lannett Com… by Lannett, citing failed Impurity/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0161-2023 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-11-09 |
| Published | 2023-01-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lannett |
| Distribution | US |
Product
Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 100 Count bottle: 0527-1632-01; NDC 1,000 bottle: 0527-1632-10
Reason
Failed Impurity/Degradation Specifications
Identifiers
| code_info | Lots: 21000279A (exp 01/2023), 20256320A (12/2022) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0161-2023%22
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