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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

IBU (ibuprofen) 600 mg Tablets Recalled for Failed Specifications

Agency Publication Date: November 15, 2024
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Summary

Dr. Reddy's Laboratories is voluntarily recalling 3,416 bottles of IBU (ibuprofen) 600 mg tablets (NDC 55111-683-05). The recall was initiated because the tablets failed to meet the required quality specifications for the medication. These products were sold in 500-count bottles and were distributed nationwide across the United States.

Risk

The tablets failed to meet established quality standards, which could potentially affect how the medication is absorbed or its overall effectiveness. No injuries or adverse events have been reported to date.

What You Should Do

  1. This recall affects 500-count bottles of IBU (ibuprofen) 600 mg tablets labeled with NDC 55111-683-05 and lot number C5406201 with an expiration date of 03/31/2028.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: IBU (ibuprofen) 600 mg Tablets (500-count bottle)
Variants: 600 mg, 500-count bottle, Tablet, Rx Only
Lot Numbers:
C5406201 (Exp 03/31/2028)
NDC:
55111-683-05

Recall #: D-0047-2025; Distributed by Dr. Reddy's Laboratories Inc., Princeton, NJ

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95620
Status: Active
Manufacturer: Dr. Reddy's Laboratories, Inc.
Sold By: Pharmacies
Manufactured In: India
Units Affected: 3416 botttles
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.