FDA Device recall Z-0408-2024
Lugol s Iodine Solution 500ML, Part Number 624-71
- FDA Device
- Class II
- ongoing
- Published 2023-12-06
On 2023-12-06 the FDA classified a Class II recall of Lugol s Iodine Solution 500ML, Part Number 624-71 by Emd Millipore, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0408-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-17 |
| Published | 2023-12-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Emd Millipore |
| Distribution | CA, NJ, WV |
Product
Lugol s Iodine Solution 500ML, Part Number 624-71
Reason
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.
Identifiers
| code_info | Lot Number 3124 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0408-2024%22
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