Silodosin Capsules (AvKARE) – Subpotent Drug (2025)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
AvKARE
Lot Codes / Batch Numbers
Lot#: BC20223A, Exp. March 31, 2025.
Products Sold
Lot#: BC20223A, Exp. March 31, 2025.
AvKARE is recalling Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manu due to 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 9. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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%)
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026