Aspen Biopharma Labs Pvt. product recalled over manufacturing violations

Recall date

February 7, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Aspen Biopharma Labs Pvt., Ltd. recalls Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and…

Recall number

D-0262-2025

FDA classification

Class II

Brand / firm

Aspen Biopharma Labs Pvt., Ltd.

Sold / distributed

Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)

Why it was recalled

CGMP Deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.