Lugol s Iodine Solution 500ML — Class II medical device recall Z-0408-2024
Ongoing recall by EMD Millipore Corporation, reported 2023-12-06, distributed in CA, NJ, WV. Due to the incorrect packaging utilized with lot 3124, there' s an improper seal between the cap and bottle. W
| Recall number | Z-0408-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | EMD Millipore Corporation, Burlington, MA, United States |
| Recall initiated | 2023-10-17 |
| Classified | 2023-11-29 |
| Reported by FDA | 2023-12-06 |
| Distributed | CA, NJ, WV |
| Quantity | 5 units |
| Reason classes | potency, packaging |
| Lot numbers | 3124 |
| Model numbers | 624-71 |
Product
Lugol s Iodine Solution 500ML, Part Number 624-71
Reason for recall
Due to the incorrect packaging utilized with lot 3124, there' s an improper seal between the cap and bottle. With an improper seal the Assay (current specification of 24.8 to 27.2 mL) is expected to continue to drop over time as iodine vapors continue to dissipate from the bottles.
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/Z-0408-2024. 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.