CLASS II Drug recall · Reported 30 Aug 2023 · FDA Enforcement Report
Lugol's (Strong Iodine Solution USP) recalled by Ecometics
Ecometics is recalling Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 05gm and potassium iodide, distributed nationwide in the US. The recall was initiated on 9 Aug 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1102-2023
- FDA event ID
- 92857
- Recalling firm
- Ecometics, Norwalk, CT
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 9 Aug 2023
- FDA classified
- 24 Aug 2023
- Reported
- 30 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 9 Aug 2023 | Recall initiated by company | |
| 24 Aug 2023 | Classified by FDA | +15 days |
| 30 Aug 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Product as listed by the FDA
Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use Vials, Rx Only, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6064-0, Ref 6064.
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 05gm and potassium iodide recalled?
Yes. Ecometics recalled Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 05gm and potassium iodide on 9 Aug 2023. The recall is Class II and its status is Completed. Recall number D-1102-2023.
Why was it recalled?
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Which lots are affected?
Lot #: 2E235A, exp: 2/2024; 2E293A, exp: 3/2024
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
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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|---|---|---|---|---|---|
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