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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Dr. Reddy's Ibuprofen Tablets Recalled for Impurity Specification Failure

Agency Publication Date: August 26, 2024
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Summary

Dr. Reddy's Laboratories, Inc. is voluntarily recalling approximately 150,040 bottles of IBU Ibuprofen Tablets (ibuprofen) in 400 mg, 600 mg, and 800 mg strengths. The recall was initiated because the tablets failed testing for impurities, showing levels of an unknown degradation product that exceed safety specifications. The affected products include 100-count and 500-count bottles distributed nationwide in the USA and Puerto Rico.

Risk

The drug failed to meet specification limits for an unknown impurity, which could potentially affect the stability or safety of the medication over time. No incidents or adverse reactions have been reported to date for these products.

What You Should Do

  1. This recall affects prescription IBU Ibuprofen Tablets (400 mg, 600 mg, and 800 mg) sold in 100-count and 500-count bottles under Dr. Reddy's Laboratories Inc. labeling.
  2. Check your medication bottle for NDC codes 55111-684-01, 55111-684-05, 55111-683-01, 5511-683-05, 55111-682-01, or 55111-682-05. See the Affected Products section below for the full list of affected codes.
  3. 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 Dr. Reddy's Laboratories, Inc. for further instructions.
  4. 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 Tablets, USP (800 mg)
Variants: 800 mg, Tablet
Lot Numbers:
C2207525 (Exp 5/31/2026)
C2212902 (Exp 11/30/2026)
C2207526 (Exp 5/31/2026)
C2210751 (Exp 9/30/2026)
C2210752 (Exp 9/30/2026)
C2212765 (Exp 11/30/2026)
C2212766 (Exp 11/30/2026)
C2301027 (Exp 12/31/2026)
C2301063 (Exp 12/31/2026)
C2301187 (Exp 12/31/2026)
C2301188 (Exp 12/31/2026)
C2301247 (Exp 12/31/2026)
C2301356 (Exp 1/31/2027)
C2301388 (Exp 1/31/2027)
C2301494 (Exp 1/31/2027)
C2301478 (Exp 1/31/2027)
C2301617 (Exp 1/31/2027)
C2303381 (Exp 2/28/2027)
C2303432 (Exp 2/28/2027)
C2303565 (Exp 2/28/2027)
C2303630 (Exp 2/28/2027)
C2303643 (Exp 2/28/2027)
C2303710 (Exp 2/28/2027)
C2303879 (Exp 3/31/2027)
C2303806 (Exp 3/31/2027)
C2303895 (Exp 3/31/2027)
C2303963 (Exp 3/31/2027)
C2304263 (Exp 3/31/2027)
C2304264 (Exp 3/31/2027)
C2304130 (Exp 3/31/2027)
C2304163 (Exp 3/31/2027)
C2304427 (Exp 3/31/2027)
NDC:
55111-684-01
55111-684-05

100 Tablets per bottle (NDC 55111-684-01) and 500 Tablets per bottle (NDC 55111-684-05).

Product: IBU Ibuprofen Tablets, USP (600 mg)
Variants: 600 mg, Tablet
Lot Numbers:
C2207527 (Exp 5/31/2026)
C2210864 (Exp 9/30/2026)
C2213018 (Exp 11/30/2026)
C2207528 (Exp 5/31/2026)
C2210860 (Exp 9/30/2026)
C2213016 (Exp 11/30/2026)
C2213017 (Exp 11/30/2026)
C2301852 (Exp 1/31/2027)
C2302056 (Exp 1/31/2027)
C2302057 (Exp 1/31/2027)
NDC:
55111-683-01
5511-683-05

100 Tablets per bottle (NDC 55111-683-01) and 500 Tablets per bottle (NDC 5511-683-05).

Product: IBU Ibuprofen Tablets, USP (400 mg)
Variants: 400 mg, Tablet
Lot Numbers:
C2207529 (Exp 5/31/2026)
C2210993 (Exp 9/30/2026)
C2207530 (Exp 5/31/2026)
C2210992 (Exp 9/30/2026)
C2210994 (Exp 9/30/2026)
C2213304 (Exp 11/30/2026)
C2213305 (Exp 11/30/2026)
NDC:
55111-682-01
55111-682-05

100 Tablets per bottle (NDC 55111-682-01) and 500 Tablets per bottle (NDC 55111-682-05).

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95098
Status: Active
Manufacturer: Dr. Reddy's Laboratories, Inc.
Sold By: Pharmacies
Manufactured In: India
Units Affected: 3 products (103,298 bottles; 31,802 bottles; 14940 bottles)
Distributed To: Nationwide
Agency Last Updated: September 3, 2024

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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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.