FDA recall D-0047-2025

Dr. Reddy's Laboratories, Inc. · Class III · drug

Product

IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05

Reason for recall

Failed Tablet/Capsule Specifications

Distribution

USA Nationwide

Key facts

Status
Ongoing
Initiation date
2024-10-29
Report date
2024-11-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0047-2025