FDA recalls finasteride drug for manufacturing compliance deviations
Aspen Biopharma Labs is recalling finasteride due to manufacturing compliance deviations. The 120 kg voluntary recall was distributed to three distributors in Hong Kong and Florida.
What this means for you
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: FDA Class II voluntary recall for manufacturing compliance deviations with no reported illnesses or injuries. The recall addresses manufacturing process compliance rather than an identified product hazard.
Plain-English summary
Aspen Biopharma Labs is recalling finasteride (NDC# 82187-1003-1) due to Current Good Manufacturing Practice (CGMP) deviations identified in manufacturing. The recalled product totals 120 kilograms.
The product was distributed to three distributors: one in Hong Kong and two in Florida. The affected lot numbers are HAFSC0040923 and HAFSC0050923, both with expiration dates in August 2027.
The manufacturer initiated this voluntary recall on February 7, 2025, and the FDA classified it as Class II on March 9, 2025. Consumers who have this product should contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.
- Manufacturer
- Aspen Biopharma Labs Pvt., Ltd.
- Category
- Drug
- Hazard
- manufacturing-compliance
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 Numbers: HAFSC0040923
- exp. date Aug-2027 HAFSC0050923
- exp. date Aug-2027
Distribution
Distribution scope not specified by the agency.
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