Silodosin Capsules recall
FDA recall D-0229-2025 · initiated Feb 4, 2025
AvKARE recalled Silodosin Capsules in Feb 2025 — an FDA Class II recall (D-0229-2025) because 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%).
May cause temporary or medically reversible harm; low probability of serious harm.
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%)
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1266 bottles
Details
- 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
- Recalling company
- AvKARE
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Feb 4, 2025
- FDA report date
- Feb 26, 2025
Frequently asked
- Was Silodosin Capsules recalled?
- AvKARE recalled Silodosin Capsules in Feb 2025 — an FDA Class II recall (D-0229-2025) because 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%). May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Silodosin Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0229-2025 was: 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%)
- Is a recalled Silodosin Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Silodosin Capsules are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot#: BC20223A, Exp. March 31, 2025.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0229-2025.