Eszopiclone Tablets — Class III drug recall D-0581-2024
Ongoing recall by Dr. Reddy's Laboratories, Inc., reported 2024-07-10, distributed in MS, OH. Failed Impurities/Degradation Specifications: Related Substances
| Recall number | D-0581-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2024-06-04 |
| Classified | 2024-07-02 |
| Reported by FDA | 2024-07-10 |
| Distributed | MS, OH |
| Quantity | 13,752 bottles |
| Reason classes | specification failure |
| NDC | 55111-0617, 55111-0617-01, 55111-0617-05, 55111-0617-09, 55111-0617-30, 55111-0617-79, 55111-0617-90, 55111-0619, 55111-0619-01, 55111-0619-05, 55111-0619-09, 55111-0619-30, 55111-0619-79, 55111-0619-90, 55111-0629, 55111-0629-01, 55111-0629-05, 55111-0629-30 |
| Lot numbers | C2302598 |
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 for recall
Failed Impurities/Degradation Specifications: Related Substances
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0581-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.