Iodine Solution Recalled for Manufacturing Compliance Deviations
Safecor Health recalls Strong Iodine Solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The prescription product was distributed in multiple lots across the U.S.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The recall is based on manufacturing process compliance deviations without a specific identified contamination or harm, constituting a precautionary recall.
Plain-English summary
Safecor Health, LLC is recalling Strong Iodine Solution (Lugol's Solution) 5% in 14 mL glass dropper bottles nationwide due to deviations from Current Good Manufacturing Practice (CGMP) compendial requirements.
The affected product comprises 166,022 bottles distributed nationwide. The affected lots include multiple batches with expiration dates ranging from November 2023 through January 2026.
Consumers and healthcare providers should stop use of the recalled product. Patients who have received this product should contact their healthcare provider or pharmacist for guidance. The product should be returned to the pharmacy where it was obtained.
The recalled product
- Product
- STRONG IODINE SOLUTION (STRONG IODINE SOLUTION)
- Brand
- STRONG IODINE SOLUTION
- Manufacturer
- Safecor Health, LLC
- Hazard
- cgmp-deviation
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 (20)
- 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
UPCs (1)
- 0348433230152
Distribution
Distributed nationwide across the United States.
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