Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Eszopiclone recalled?

Yes — there is an active recall. 1 ongoing FDA recall mention Eszopiclone (4 total). Check the affected lots below.

Most common reason: Impurity / degradation (1 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Eszopiclone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Eszopiclone recalls on record

none so far in 2026; 4 on record, newest first
Class III · Low risk

Eszopiclone Tablets

Failed Impurities/Degradation Specifications: Related Substances

Ongoing Impurity / degradation Dr. Reddy's Laboratories, Inc. NDC 55111-629-30 D-0581-2024
Class II · Moderate risk

Eszopiclone Tablets

Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.

Terminated Failed specification Macleods Pharma Usa Inc NDC 33342-299-07 D-1174-2022
Class II · Moderate risk

Eszopiclone

Labeling:Label Mixup; ESZOPICLONE, Tablet, 3 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904582460, Pedigree: W002779, EXP: 6/6/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-680-2014