Strong Iodine Solution (Safecor Health) – CGMP Deviation (2023)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Safecor Health, LLC
Lot Codes / Batch Numbers
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
Products Sold
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
Safecor Health, LLC is recalling Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX due to CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026