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.
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 2/5 (Moderate).
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
- Affected units
- 166,022
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.
Related recalls
Same manufacturer · Safecor Health, LLC
See all →- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
Same hazard · cgmp deviation
See all →- SevereBaxter Recalls Vasopressin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateLexia LLC Recalls Broadway Joe's Pain Cream Due to CGMP Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
Similar recalls
- HighLugol's Strong Iodine Solution Recalled Due to Manufacturing Quality Deviations
FDA (Drugs) · 2023-08-30
- ModerateFDA Recalls Cromolyn Sodium Eye Drops Nationwide for Manufacturing Defects
FDA (Drugs) · 2023-01-25
- HighProparacaine Ophthalmic Solution Recalled for Manufacturing Quality Deviations
FDA (Drugs) · 2023-01-25
- HighEye-drop drug recall: Timolol solution due to manufacturing deviations
FDA (Drugs) · 2023-01-25
- ModerateIodine Solution Recalled for Improper Bottle Cap Seal
FDA (Devices) · 2023-12-06
- HighDiphenhydramine Solution Recalled Due to Manufacturing Control Deviations
FDA (Drugs) · 2022-09-14