Dutasteride Capsules — Class II drug recall D-0661-2020
Terminated recall by AVKARE Inc., reported 2020-01-22, distributed nationwide. Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
| Recall number | D-0661-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVKARE Inc., Pulaski, TN, United States |
| Recall initiated | 2020-01-07 |
| Classified | 2020-01-13 |
| Reported by FDA | 2020-01-22 |
| Terminated | 2021-07-14 |
| Distributed | Nationwide (US) |
| Quantity | 3,989 cartons |
| Reason classes | specification failure |
| NDC | 50268-0282-13 |
| Lot numbers | 23647, 24532, 25246 |
| Expiration dates | 2020-06, 2020-10, 2021-02 |
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 for recall
Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0661-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.