The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1102-2023·Announced 2023-08-30

Lugol's Strong Iodine Solution Recalled Due to Manufacturing Quality Deviations

Ecometics, Inc. is recalling Lugol's Strong Iodine Solution nationwide due to manufacturing quality deviations. Consumers with affected prescription vials should consult their healthcare provider.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving manufacturing practice violations (CGMP deviations). No illnesses, injuries, or deaths reported. Classified as High due to the manufacturing quality defect affecting a prescription pharmaceutical, though the specific nature of the defect and potential harm are not detailed in this notice.

Plain-English summary

Ecometics, Inc. is recalling Lugol's Strong Iodine Solution USP (8mL single-use vials, prescription-only) manufactured for CooperSurgical. The product contains 0.05 grams of iodine and 0.100 grams of potassium iodide per mL (NDC 59365-6064-0).

The recall was issued because the product was not manufactured under current good manufacturing practices (CGMP), meaning the manufacturing process did not meet FDA quality standards.

Approximately 38,486 vials were distributed nationwide in the USA. The affected lots are: Lot #2E235A (expiration 2/2024) and Lot #2E293A (expiration 3/2024).

Consumers who have this product should contact their healthcare provider or pharmacist for guidance. Do not use vials from the affected lots.

The recalled product

Product
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.
Manufacturer
Ecometics, Inc.
Category
Drug — Pharmaceutical / Iodine Solution
Hazard
Affected units
38,486

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot #: 2E235A
  • exp: 2/2024
  • 2E293A
  • exp: 3/2024

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Ecometics, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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