Lugol's — Class II drug recall D-1102-2023
Completed recall by Ecometics, Inc., reported 2023-08-30, distributed nationwide. CGMP Deviations: Products not manufactured under current good manufacturing practices.
| Recall number | D-1102-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ecometics, Inc., Norwalk, CT, United States |
| Recall initiated | 2023-08-09 |
| Classified | 2023-08-24 |
| Reported by FDA | 2023-08-30 |
| Distributed | Nationwide (US) |
| Quantity | 38,486 vials |
| Reason classes | cgmp |
| NDC | 59365-6064-00 |
| Lot numbers | 2E235A, 2E293A |
| Model numbers | 6064 |
| Expiration dates | 2024-02, 2024-03 |
Product
Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use Vials, Rx Only, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6064-0, Ref 6064.
Reason for recall
CGMP Deviations: Products not manufactured under current good manufacturing practices.
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-1102-2023. 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.