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Drug FDA Class III Ongoing Failed specifications

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

Dr. Reddy's Laboratories, Inc. Published Nov 27, 2024

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Dr. Reddy's Laboratories, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed Tablet/Capsule Specifications

Hazards

Failed Tablet Specifications · primary

Affected products (1)

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

IBU · 3416 botttles

NDC: 55111-682, 55111-683, 55111-684, 55111-682-09, 55111-682-01, 55111-682-05, 55111-683-30, 55111-683-50, 55111-683-09, 55111-683-01, 55111-683-05, 55111-684-30, 55111-684-50, 55111-684-60, 55111-684-09, 55111-684-01, 55111-684-05
Code info: Lot #: C5406201, Exp 03/31/2028

Affected areas

Nationwide

Timeline

  1. Initiated
    Oct 29, 2024
  2. Published
    Nov 27, 2024
Recall number
D-0047-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.