Recalls / Class II
Class IID-0229-2025
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 name
- Silodosin
- Generic name
- Silodosin
- Active ingredient
- Silodosin
- Route
- Oral
- NDCs
- 42291-777, 42291-778
- FDA application
- ANDA209745
- Affected lot / code info
- Lot#: BC20223A, Exp. March 31, 2025.
Why it was recalled
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%)
Recalling firm
- Firm
- AvKARE
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, N/A, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 1266 bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2025-02-04
- FDA classified
- 2025-02-20
- Posted by FDA
- 2025-02-26
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0229-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.