FDA Recall D-0229-2025

AvKARE · Pulaski, TN

Class II Ongoing 464 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot#: BC20223A, Exp. March 31, 2025.

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%)

Recall record

Recall number: D-0229-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: USA Nationwide
Recall initiated: 2025-02-04
Classified by FDA Center: 2025-02-20
FDA published: 2025-02-26
Recalling firm: AvKARE
Firm location: Pulaski, TN

Drug identification

Brand name(s): SILODOSIN
Generic name(s): SILODOSIN
Manufacturer(s): AvKARE
NDC(s): 42291-777, 42291-778
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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