FDAFDA · Food and drugs·Recall number D-0229-2025
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
Published February 26, 2025 · Recall initiated: February 4, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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%)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SILODOSIN
- Manufacturer
- AvKARE
- Distributor
- USA Nationwide
- Lot
- Lot#: BC20223A, Exp. March 31, 2025.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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