Prescription Drug Silodosin Recalled Due to Subpotency and Out-of-Specification Impurity
AvKARE is recalling Silodosin 8mg capsules nationwide due to subpotent drug levels and out-of-specification impurity found in stability testing. The affected lot is BC20223A, expiring March 31, 2025.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving subpotent drug levels marginally below specification, with no reported illnesses or injuries. The hazard is theoretical quality control failure without reported acute harm.
Plain-English summary
AvKARE is recalling Silodosin 8mg capsules (NDC 42291-778-90) nationwide. The recall affects 1,266 bottles of lot BC20223A, which expire on March 31, 2025. Silodosin is a prescription medication used to treat benign prostatic hyperplasia.
The recall was initiated due to quality control findings in stability testing. Testing of an 18-month stability sample revealed that the drug assay (active ingredient content) measured 94.9%, below the required specification of 95.0% to 105.0%. Additionally, a dehydro impurity was detected at 0.654% in the same sample.
Consumers and healthcare providers should check whether they have this product. The affected lot number is BC20223A.
Consumers should contact their healthcare provider or pharmacist before discontinuing the medication. AvKARE and healthcare providers can provide information about alternatives or replacements.
The recalled product
- Product
- SILODOSIN (SILODOSIN)
- Brand
- SILODOSIN
- Manufacturer
- AvKARE
- Category
- Drug — Prescription
- Affected units
- 1,266
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot#: BC20223A
- Exp. March 31
- 2025.
Distribution
Distributed nationwide across the United States.
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