RecallRadar

FDA Drug recall D-0581-2024

Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd

On 2024-07-10 the FDA classified a Class III recall of Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd by Dr Reddy S Laboratories, citing failed Impurities/Degradation Specifications: Related Substances.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0581-2024
ClassificationClass III
Statusongoing
Initiated2024-06-04
Published2024-07-10
Last updated2026-09-13 11:52 UTC
CompanyDr Reddy S Laboratories
DistributionMS, OH

Product

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

Reason

Failed Impurities/Degradation Specifications: Related Substances

Identifiers

ndc55111-629-30
ndc55111-629-01
ndc55111-629-05
ndc55111-619-30
ndc55111-619-90
ndc55111-619-01
ndc55111-619-05
ndc55111-619-79
ndc55111-619-09
ndc55111-617-30
ndc55111-617-90
ndc55111-617-01
ndc55111-617-05
ndc55111-617-79
ndc55111-617-09
code_infoLot#: C2302598, Exp 2/29/2025

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0581-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.