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

FDA recall notice · announced February 26, 2025 · Avkare

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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%)

Notes

Distribution: USA Nationwide
Lot/code information: Lot#: BC20223A, Exp. March 31, 2025.
Quantity: 1266 bottles
Status: Ongoing
Products in this recall event:
- 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 (D-0229-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.