CLASS II ONGOING Drug recall · Reported 26 Feb 2025 · FDA Enforcement Report
Silodosin Capsules, 8mg recalled by AvKARE
AvKARE is recalling Silodosin Capsules, 8mg, distributed nationwide in the US. The recall was initiated on 4 Feb 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0229-2025
- FDA event ID
- 96247
- Recalling firm
- AvKARE, Pulaski, TN
- Brand
- Silodosin
- Manufacturer
- AvKARE
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Feb 2025
- FDA classified
- 20 Feb 2025
- Reported
- 26 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 4 Feb 2025 | Recall initiated by company | |
| 20 Feb 2025 | Classified by FDA | +16 days |
| 26 Feb 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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%)
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Is Silodosin Capsules, 8mg recalled?
Yes. AvKARE recalled Silodosin Capsules, 8mg on 4 Feb 2025. The recall is Class II and its status is Ongoing. Recall number D-0229-2025.
Why was it 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%)
Which lots are affected?
Lot#: BC20223A, Exp. March 31, 2025.
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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