Eszopiclone Tablets Recalled for Failed Impurity and Degradation Specifications
Dr. Reddy's Laboratories is recalling 13,752 bottles of Eszopiclone 1mg tablets due to failed impurity and degradation specifications. Lot C2302598 was distributed in Ohio and Mississippi.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA has classified this as a Class III recall, indicating use of the product is unlikely to cause adverse health consequences. No illnesses or injuries have been reported. The recall addresses a manufacturing quality control issue rather than an immediate safety hazard.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Eszopiclone 1mg tablets in 30-count bottles. The affected product is lot C2302598 with expiration date February 29, 2025 and NDC 55111-629-30. A total of 13,752 bottles were distributed.
The recall was initiated because the tablets failed to meet quality specifications for impurities and degradation. Specifically, the product did not pass testing for related substances—contaminants or byproducts that must remain below specified limits. No illnesses or injuries have been reported.
The affected tablets were distributed in Ohio and Mississippi. Patients currently taking this medication should check their bottle label for lot number C2302598. If you have this product, contact your pharmacist or doctor about whether to return it or continue taking it.
The recalled product
- Product
- ESZOPICLONE (ESZOPICLONE)
- Brand
- ESZOPICLONE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Insomnia Medication
- Hazard
- impurity
- degradation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: C2302598
- Exp 2/29/2025
UPCs (3)
- 0355111617013
- 0355111629306
- 0355111619017
Distribution
Distributed in 2 states:
- MS
- OH
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