AvKARE: Drug Recall

Recall #D-0229-2025 · 02/04/2025

Class II: Risk

Recall Details

Recall Number
D-0229-2025
Classification
Class II
Product Type
Drug
Recalling Firm
AvKARE
Status
Ongoing
Date Initiated
02/04/2025
Location
Pulaski, TN, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1266 bottles

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%)

Product Description

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

Distribution Pattern

USA Nationwide

Other Recalls by AvKARE

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.