AvKARE recalls 8mg Silodosin capsules due to subpotent drug levels. This may affect prescription medication safety. Contact for details.
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%)
AvKARE is recalling 8mg Silodosin capsules that may have lower-than-stated drug levels. This could mean the medication isn't as effective as it should be, potentially leading to treatment issues.
The capsules show lower-than-stated drug levels (94.9% instead of 95.0% minimum) and contain a small amount of a chemical impurity. This could reduce effectiveness but is unlikely to cause immediate harm.
Prescription patients using the recalled Silodosin capsules. Those with specific medical conditions requiring precise dosing may be at slightly higher risk.
Check for the 8mg Silodosin capsules in a 90-count bottle with NDC 42291-778-90. The lot number BC20223A was manufactured for expiration March 31, 2025.
Verify the product label for NDC 42291-778-90 and lot number BC20223A.
The recall is for subpotent drug levels, which may reduce effectiveness but is not expected to cause serious injury.
Check for the 8mg Silodosin capsules with NDC 42291-778-90 and lot number BC20223A.
The recall does not specify a remedy, so contact your healthcare provider for guidance.
We’ve drafted a message you can send AvKARE to request your refund or repair — edit it as you like.
Subject: Recall D-0229-2025 — AvKARE AvKARE Hello, I own a AvKARE that is covered by recall D-0229-2025 from AvKARE. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
