CLASS II ONGOING Device recall · Reported 6 Dec 2023 · FDA Enforcement Report
Lugol s Iodine Solution recalled by EMD Millipore
EMD Millipore is recalling Lugol s Iodine Solution, distributed in California, New Jersey, West Virginia. The recall was initiated on 17 Oct 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0408-2024
- FDA event ID
- 93318
- Recalling firm
- EMD Millipore, Burlington, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Oct 2023
- FDA classified
- 29 Nov 2023
- Reported
- 6 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 17 Oct 2023 | Recall initiated by company | |
| 29 Nov 2023 | Classified by FDA | +43 days |
| 6 Dec 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Lugol s Iodine Solution 500ML, Part Number 624-71
Where it was distributed
US States: CA, NJ, WV
Questions about this recall
Is Lugol s Iodine Solution recalled?
Yes. EMD Millipore recalled Lugol s Iodine Solution on 17 Oct 2023. The recall is Class II and its status is Ongoing. Recall number Z-0408-2024.
Why was it recalled?
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.
Which lots are affected?
Lot Number 3124
Where was it sold?
US States: CA, NJ, WV
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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