FDA recall D-0306-2025

Product

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

Reason for recall

Failed dissolution specifications: lower than specifications

Distribution

U.S.A. nationwide

Key facts

Status

Ongoing

Initiation date

2025-03-17

Report date

2025-04-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

ISELIN, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0306-2025