# FDA recall D-0229-2025

> **AvKARE** · Class II · drug recall initiated 2025-02-04.

## 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%)

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0229-2025
- **Recalling firm:** AvKARE
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-02-04
- **Report date:** 2025-02-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pulaski, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0229-2025

## Citation

> AI Analytics. FDA recall D-0229-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0229-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*