BIOCON PHARMA INC: Drug Recall

Recall #D-0306-2025 · 03/17/2025

Class II: Risk

Recall Details

Recall Number
D-0306-2025
Classification
Class II
Product Type
Drug
Recalling Firm
BIOCON PHARMA INC
Status
Ongoing
Date Initiated
03/17/2025
Location
ISELIN, NJ, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2184 bottles

Reason for Recall

Failed dissolution specifications: lower than specifications

Product Description

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

Distribution Pattern

U.S.A. nationwide

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.