BIOCON PHARMA INC recalls Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08…

Recall date

March 17, 2025

Source

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

Recall number

D-0306-2025

FDA classification

Class II

Brand / firm

BIOCON PHARMA INC

Sold / distributed

U.S.A. nationwide

Why it was recalled

Failed dissolution specifications: lower than specifications

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

What was recalled

Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377-079-13