Silodosin Capsules — Class II drug recall D-0229-2025
Ongoing recall by AvKARE, reported 2025-02-26, distributed nationwide. Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and
| Recall number | D-0229-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AvKARE, Pulaski, TN, United States |
| Recall initiated | 2025-02-04 |
| Classified | 2025-02-20 |
| Reported by FDA | 2025-02-26 |
| Distributed | Nationwide (US) |
| Quantity | 1,266 bottles |
| Reason classes | potency, specification failure |
| NDC | 42291-0777, 42291-0777-30, 42291-0778, 42291-0778-90 |
| Lot numbers | BC20223A |
| Expiration dates | 2025-03-31 |
Product
Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals of NY, LLC, NY 11719, NDC 42291-778-90
Reason for recall
Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
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-0229-2025. 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.