Reported Nov 8, 2023 · Terminated

Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor…

Safecor Health, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Safecor Health, LLC · 317 New Boston St · Woburn, MA · 01801-6231

Is this the product you have?

  • Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor Health, LLC, Woburn, MA 01801. NDC# 48433-230-15
Lot codes and dates
    • Lot # 21A0073
    • Exp 11/30/2023
    • 21A0091
    • Exp. 12/31/2023
    • 21A0103
    • Exp 01/31/2024
    • 21A0135
    • Exp 03/31/2024
    • 22A0011
    • Exp 06/30/2024
    • 22A0019
    • Exp 07/31/2024
    • 22A0057
    • Exp 09/30/2024
    • 22A0083
    • Exp 11/30/2024
    • 22A0104
    • Exp 12/31/2024
    • 22A0110
    • Exp 01/31/2025
    • 22A0150
    • Exp 03/31/2025
    • 23A0007
    • Exp 06/30/2025
    • 23A0041
    • Exp 09/30/2025
    • 23A0045
    • Exp 11/30/2025
    • 23A0058
    • Exp 11/30/2025
    • 23A0067
    • Exp 11/30/2025
    • 23A0080
    • Exp 12/31/2025
    • 23A0090
    • Exp 01/31/2026
Amount recalled
166,022 bottles

Where it was sold

  • Nationwide

Why it was recalled

CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Nov 8, 2024 · Data as of Sep 19, 3:27 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.