Z-0408-2024Class II

Lugol s Iodine Solution 500ML, Part Number 624-71

Name: Z-0408-2024 Lugol s Iodine Solution 500ML, Part Number 624-71
Creator: EMD Millipore Corporation
Published: 2023-10-17
License: https://open.fda.gov/license/

EMD Millipore Corporation / initiated 2023-10-17 / Open, Classified / root cause: packaging

FDA source

EMD Millipore Corporation began a recall of Lugol s Iodine Solution 500ML, Part Number 624-71 on 2023-10-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0408-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-17
Posted: 2023-11-29
Recalling firm: EMD Millipore Corporation
Product: Lugol s Iodine Solution 500ML, Part Number 624-71
Product code: IAM Solution, Lugol'S
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.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: A Product Recall notification letter dated 10/17/23 was sent to customers. Required/Recommended Action Please immediately examine your inventory to determine if you have any remaining impacted product and forward a copy of this letter to the personnel in your organization that utilize this product and/or need to be made aware of this issue. Please discard this material and request a replacement. Please complete attachment 1 form acknowledging receipt of this letter and return to the noted email address. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this issue. Your notification to customers should include a copy of this notification. You may contact Technical or Customer Service to discuss an appropriate solution for your needs. If you would like more information about this FCA notification, please contact your local representative or use the link www.sigmaaldrich.com/offices for our website to obtain the phone number and/or email address of your local office.
Quantity in commerce: 5 units
Distribution: US States: CA, NJ, WV
Product codes and lots: Lot Number 3124

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0408-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0408-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-06	2023-11-29

Product code IAM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)