FDA Drug recall D-0461-2025
Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC…
- FDA Drug
- Class II
- ongoing
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class II recall of Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC… by Avkare, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0461-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-09 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Avkare |
| Distribution | US |
Product
Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15
Reason
Failed Dissolution Specifications
Identifiers
| ndc | 50268-167-11 |
|---|---|
| ndc | 50268-167-15 |
| code_info | Lot # 47947, Exp 05/31/2026 |
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-0461-2025%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.