Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Silodosin Capsules Recalled by AvKARE Due to Subpotent Drug: Out of Specification (OOS) result for...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact AvKARE directly.
Affected Products
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
Quantity: 1266 bottles
Why Was This Recalled?
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%)
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About AvKARE
AvKARE has 20 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report