CLASS II Drug recall · Reported 8 Nov 2023 · FDA Enforcement Report
Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%) recalled
Safecor Health is recalling Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), distributed nationwide in the US. The recall was initiated on 19 Oct 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0082-2024
- FDA event ID
- 93220
- Recalling firm
- Safecor Health, Woburn, MA
- Manufacturer
- Safecor Health, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Oct 2023
- FDA classified
- 1 Nov 2023
- Reported
- 8 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 19 Oct 2023 | Recall initiated by company | |
| 1 Nov 2023 | Classified by FDA | +13 days |
| 8 Nov 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Product as listed by the FDA
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
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Which lots are affected?
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
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Safecor Health
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 2.5 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 5 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 5 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 10 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 20 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |