IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories...

FDA Recall #D-0047-2025 — Class III — October 29, 2024

Recall #D-0047-2025 Date: October 29, 2024 Classification: Class III Status: Ongoing

Product Description

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

Recalling Firm

Dr. Reddy's Laboratories, Inc. — Princeton, NJ

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

3416 botttles

Distribution

USA Nationwide

Code Information

Lot #: C5406201, Exp 03/31/2028

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated