FDA Drug recall D-0661-2020
Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 502…
- FDA Drug
- Class II
- terminated
- Published 2020-01-22
On 2020-01-22 the FDA classified a Class II recall of Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 502… by Avkare, citing failed Impurities/Degradation Specifications: High out of specification results for related compounds.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0661-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-07 |
| Published | 2020-01-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Avkare |
| Distribution | US |
Product
Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-282-13.
Reason
Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
Identifiers
| code_info | Lots: 25246, Exp. 02/2021; 24532, Exp. 10/2020; 23647, Exp. 06/2020 |
|---|
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-0661-2020%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.