Lower risk Drug recall · FDA · Published October 19, 2023

Safecor Strong Iodine Solution Recall: CGMP Deviations Risk

Safecor Health recalls iodine solution bottles due to missing USP manufacturing standards. This medication is prescription-only and may not be safe for use.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0082-2024Drug Safecor ›

Lower-risk recall

CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.

Take action

Contact the company

Recalling firmSafecor Health, LLC317 New Boston St · Woburn, MA 01801-6231

✎ GovInfoNow plain-language explainer

Safecor Health is recalling prescription iodine solution bottles because they were made without proper USP manufacturing standards. This could mean the product isn't safe for medical use. Read more at govinfonow.com/recall/33050-safecor-strong-iodine-solution-recall-cgmp-deviations-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/33050-safecor-strong-iodine-solution-recall-cgmp-deviations-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0082-2024

Cite this page

“Safecor Strong Iodine Solution Recall: CGMP Deviations Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33050-safecor-strong-iodine-solution-recall-cgmp-deviations-risk. Based on FDA recall #D-0082-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0082-2024%22&limit=1).

The FDA announced on Oct. 19, 2023, that Safecor Health, LLC is recalling Strong Iodine Solution U.S.P. (Lugol's Solution) due to CGMP deviations. The drug fails to meet USP compendial requirements for quality control.

How to tell if you have it

Brand: Safecor
Product: Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only
NDC# 48433-230-15
Lot codes: 21A0073, 21A0091, 21A0103, 21A0135, 22A0011, 22A0019, 22A0057, 22A0083, 22A0104, 22A0110, 22A0150, 23A0007, 23A0041, 23A0045, 23A0058, 23A0067, 23A0080, 23A0090

The hazard

The recall is due to the absence of USP CGMP compendial requirements. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Safecor Health, LLC has 11 other recalls on record since March 2, 2015. Other recent recalls of similar products include Wells Pharma Fentanyl Citrate Injectable Solution Recall (April 1, 2026) and Baxter Clindamycin Injection Recall (Aug. 6, 2026).

How to tell if you have this one

Look for Safecor Health's Strong Iodine Solution (Lugol's Solution) 14 mL glass dropper bottles in boxes. The product has NDC# 48433-230-15 and specific lot numbers with expiration dates listed in the recall.

Brand
Safecor
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the NDC number and lot numbers listed in the recall to confirm if your product is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Distributed Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 13 months after the firm started it.

Oct 19, 2023Firm started the recall
Nov 1, 2023FDA classified it Class II
Nov 8, 2023Published in FDA’s Enforcement Report
Nov 8, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Safecor recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/33050-safecor-strong-iodine-solution-recall-cgmp-deviations-risk">Safecor Strong Iodine Solution Recall: CGMP Deviations Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0082-2024 (October 19, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0082-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.