FDA Drugs recall ·

IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr recall

Recall number
D-0047-2025
Date
(initiated October 29, 2024)
Company / brand
Dr. Reddy's Laboratories, Inc.
107 College Rd E, Princeton, NJ, United States
Category
Drugs › Class III
Classification
Class III
Status
Ongoing
Units affected
3416 botttles
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

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

Why was it recalled?

Failed Tablet/Capsule Specifications

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Lot #: C5406201, Exp 03/31/2028

Distribution

USA Nationwide

What does Class III mean?

Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).

Source: FDA (drugs), recall D-0047-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.