Unrated Drug recall · FDA · Published June 4, 2024

Dr. Reddy's Eszopiclone Tablets 1mg Recall: Impurities Risk

Dr. Reddy's recalls 1mg Eszopiclone tablets due to potential impurities. Affected lots: C2302598, expiring 2/29/2025. No specific remedy stated in recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0581-2024Drug Dr. Reddy's ›

Recall notice

Failed Impurities/Degradation Specifications: Related Substances

Take action

Contact the company

Recalling firmDr. Reddy's Laboratories, Inc.107 College Rd E · Princeton, NJ 08540-6623

✎ GovInfoNow plain-language explainer

Dr. Reddy's is recalling 1mg Eszopiclone tablets that may contain impurities. This could pose a risk to users, though the recall does not specify a remedy or how to check for affected products. Read more at govinfonow.com/recall/32636-dr-reddy-s-eszopiclone-tablets-1mg-recall-impurities-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/32636-dr-reddy-s-eszopiclone-tablets-1mg-recall-impurities-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0581-2024

Cite this page

“Dr. Reddy's Eszopiclone Tablets 1mg Recall: Impurities Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32636-dr-reddy-s-eszopiclone-tablets-1mg-recall-impurities-risk. Based on FDA recall #D-0581-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0581-2024%22&limit=1).

The FDA announced on June 4, 2024, that Dr. Reddy's Laboratories, Inc. voluntarily recalled Eszopiclone Tablets, USP 1mg due to failed impurity specifications. The recall affects 13,752 bottles distributed in Ohio and Mississippi.

How to tell if you have it

Brand: Dr. Reddy's
Product: Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only
Manufacturer: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA
NDC: 55111-629-30
Lot#: C2302598
Expiration: 2/29/2025
Distribution: OH, MS

The hazard

The recall is due to failed impurity specifications related to substances in the drug. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show Dr. Reddy's Laboratories, Inc. has 85 other recalls on record since 2012-04-09. Other recent recalls of similar products include Unichem Bisoprolol/Hydrochlorothiazide Tablets Recall (2026-01-21), Novadoz Glycopyrrolate Oral Solution Recall (2025-12-15), and Macleods Olanzapine Tablets 5mg Recall (2026-08-27).

How to tell if you have this one

Check for the lot number C2302598 on the packaging. The product is a 1mg Eszopiclone tablet bottle with NDC 55111-629-30, manufactured in India and expiring 2/29/2025.

Brand
Dr. Reddy's
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the lot number C2302598 on the packaging of the Eszopiclone tablets.

Where it went and when

Where it was distributed

Distributed in Mississippi and Ohio.

FDA distribution: “OH, MS” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Mississippi, Ohio.

Recall timeline

FDA published this recall 36 days after the firm started it.

Jun 4, 2024Firm started the recall
Jul 2, 2024FDA classified it Class III
Jul 10, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Dr. Reddy's recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/32636-dr-reddy-s-eszopiclone-tablets-1mg-recall-impurities-risk">Dr. Reddy's Eszopiclone Tablets 1mg Recall: Impurities Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0581-2024 (June 4, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0581-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.