Strong Iodine Solution U — Class II drug recall D-0082-2024
Terminated recall by Safecor Health, LLC, reported 2023-11-08, distributed nationwide. CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
| Recall number | D-0082-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Safecor Health, LLC, Woburn, MA, United States |
| Recall initiated | 2023-10-19 |
| Classified | 2023-11-01 |
| Reported by FDA | 2023-11-08 |
| Terminated | 2024-11-08 |
| Distributed | Nationwide (US) |
| Quantity | 166,022 bottles |
| Reason classes | cgmp |
| NDC | 48433-0230, 48433-0230-15 |
| Lot numbers | 21A0073, 21A0091, 21A0103, 21A0135, 22A0011, 22A0019, 22A0057, 22A0083, 22A0104, 22A0110, 22A0150, 23A0007, 23A0041, 23A0045, 23A0058, 23A0067, 23A0080, 23A0090 |
| Expiration dates | 2023-11-30, 2023-12-31, 2024-01-31, 2024-03-31, 2024-06-30, 2024-07-31, 2024-09-30, 2024-11-30, 2024-12-31, 2025-01-31, 2025-03-31, 2025-06-30, 2025-09-30, 2025-11-30, 2025-12-31, 2026-01-31 |
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
Reason for recall
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0082-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.