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%)
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
Lot numbers, UPCs & expiration codes
Lot#: BC20223A, Exp. March 31, 2025.
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0229-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 4, 2025
- FDA report date
- Feb 26, 2025
- Quantity
- 1266 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AvKARE
Original FDA data
Every field from FDA enforcement report D-0229-2025, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Ongoing
- Country
- United States
- Event ID
- 96247
- Address
- 615 N 1st St
- Code information
- Lot#: BC20223A, Exp. March 31, 2025.
- Postal code
- 38478-2403
- Report date
- Feb 26, 2025
- Product type
- Drugs
- Recall number
- D-0229-2025
- Classification
- Class II
- Recalling firm
- AvKARE
- 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%)
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Feb 4, 2025
- Initial firm notification
- Letter
- Center classification date
- Feb 20, 2025