Silodosin Capsules Recalled Due to Subpotency Issues

Amneal Pharmaceuticals of NY, LLC has issued a voluntary recall of Silodosin Capsules 8mg, packaged in 90-count bottles. The medication, manufactured by and distributed under the AvKARE label, is being recalled due to subpotency concerns. The recall was initiated on February 4, 2025, and affects lot $BC20223A (expiration date 3/31/25). Stability testing at 18 months detected an out-of-specification result for dehydro impurity (0.654%) and a low assay result of 94.9%, which falls slightly below the acceptable specification range of 95.0% to 105%.

The US Food and Drug Administration (FDA) has classified this as a Class II recall, indicating that exposure to the subpotent product may cause temporary or medically reversible health consequences. The FDA has not reported any adverse events associated with the recall, but pharmacists should be aware that affected bottles were distributed nationwide across the US. The company has notified its consignees through a formal letter, but no public press release has been issued at this time.

Silodosin is a selective alpha-1 adrenergic receptor antagonist indicated for the treatment of benign prostatic hyperplasia, a condition that leads to urinary difficulties in men due to an enlarged prostate. While a slight reduction in potency may not cause immediate harm, prolonged exposure to a subpotent formulation could reduce treatment effectiveness, leading to inadequate symptom relief. Pharmacists should check inventory for lot #BC20223A and advise patients on potential concerns regarding the recall.