Medications & Supplements/Prescription Drugs

Safecor Strong Iodine (Lugol's Solution) Recalled for Manufacturing Issues

Agency Publication Date: October 31, 2023

Summary

Safecor Health, LLC is recalling approximately 166,022 bottles of Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%). The recall is due to manufacturing deviations that did not meet required quality standards. These 14 mL glass dropper bottles were distributed nationwide to pharmacies and healthcare providers. No injuries or illnesses have been reported to date regarding this issue.

Risk

The product may not meet established safety or potency standards due to deviations in the manufacturing process. This could lead to the medication being less effective or potentially causing unexpected side effects for patients.

What You Should Do

This recall affects Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%) sold in 14 mL glass dropper bottles under the Safecor Health brand (NDC 48433-230-15).
Check the lot number and expiration date printed on the bottle label or the box to see if your product is included. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Strong Iodine Solution U.S.P. (Lugol's Solution) (14 mL)by Safecor Health

Variants: Iodine 5%, Glass Dropper Bottle, RX Only

Lot Numbers:

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)

NDC:

48433-230-15

Recall #: D-0082-2024; Product distributed in 14 mL glass dropper bottles in a box.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93220

Status: Resolved

Manufacturer: Safecor Health, LLC

Sold By: Pharmacies; Healthcare Providers

Manufactured In: United States

Units Affected: 166,022 bottles

Distributed To: Nationwide

Agency Last Updated: November 1, 2023

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%) sold in 14 mL glass dropper bottles under the Safecor Health brand (NDC 48433-230-15).

Check the lot number and expiration date printed on the bottle label or the box to see if your product is included. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Strong Iodine Solution U.S.P. (Lugol's Solution) (14 mL)by Safecor Health

Variants: Iodine 5%, Glass Dropper Bottle, RX Only

Lot Numbers:

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)

NDC:

48433-230-15

Recall #: D-0082-2024; Product distributed in 14 mL glass dropper bottles in a box.