Official recall record
Lugol s Iodine Solution 500ML, Part Number 624-71
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-10-17
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- EMD Millipore Corporation
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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