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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

Dr. Reddy's Eszopiclone Tablets Recalled for Failed Impurity Specifications

Agency Publication Date: July 2, 2024
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Summary

Dr. Reddy's Laboratories, Inc. has voluntarily recalled 13,752 bottles of Eszopiclone (1mg) tablets. This prescription sleep medication was found to contain impurities or degradation products that exceeded approved safety specifications during testing. The recall affects 30-count bottles of Eszopiclone Tablets, USP 1mg CIV, manufactured by Dr. Reddy's Laboratories Limited in India.

Risk

Taking medication that has higher levels of impurities or degradation products than allowed can lead to unexpected side effects or may cause the drug to be less effective at treating your condition. No specific adverse events have been reported for this recall.

What You Should Do

  1. This recall affects Dr. Reddy's Eszopiclone Tablets, USP 1mg CIV, sold in 30-count bottles under NDC 55111-629-30. Only lot number C2302598 with an expiration date of 2/29/2025 is included in this recall.
  2. If you have health concerns about using this medication, contact your healthcare provider or pharmacist immediately.
  3. 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 assistance.

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: Eszopiclone Tablets, USP 1mg CIV (30-count bottle)
Variants: 1 mg, Tablet
Lot Numbers:
C2302598 (Exp 2/29/2025)
NDC:
55111-629-30

Recall #: D-0581-2024; Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94754
Status: Active
Manufacturer: Dr. Reddy's Laboratories, Inc.
Sold By: Retail Pharmacies
Manufactured In: India
Units Affected: 13,752 bottles
Distributed To: Ohio, Mississippi

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.