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Drug FDA Class III Ongoing Failed specifications

Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, NDC 55111-629-30

Dr. Reddy's Laboratories, Inc. Published Jul 10, 2024

Risk level

Class III

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

Severity score 30/100

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 Impurities/Degradation Specifications: Related Substances

Hazards

Failed Impurities/Degradation Specifications - Related Substances · primary

Affected products (1)

Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, NDC 55111-629-30

ESZOPICLONE · 13,752 bottles

NDC: 55111-617, 55111-629, 55111-619, 55111-629-30, 55111-629-01, 55111-629-05, 55111-619-30, 55111-619-90, 55111-619-01, 55111-619-05, 55111-619-79, 55111-619-09, 55111-617-30, 55111-617-90, 55111-617-01, 55111-617-05, 55111-617-79, 55111-617-09
Code info: Lot#: C2302598, Exp 2/29/2025

Affected areas

MississippiOhio

Timeline

  1. Initiated
    Jun 4, 2024
  2. Published
    Jul 10, 2024
Recall number
D-0581-2024
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.