Gordon Laboratories recalls Monsel's Solution with higher iron levels
Gordon Laboratories recalls Monsel's (Ferric Subsulfate) Solution due to higher iron content than labeled. This superpotent drug may cause serious health risks if misused.
Recall notice
Superpotent Drug: contains higher levels of Iron than labeled.
Contact the company
What happened, in plain English
Gordon Laboratories is recalling Monsel's (Ferric Subsulfate) Solution because it contains higher levels of iron than labeled. This could lead to serious health risks if used incorrectly. Read more at govinfonow.com/recall/39377-gordon-laboratories-recalls-monsel-s-solution-with-higher-iron-levels.
Source Summary by GovInfoNow · govinfonow.com/recall/39377-gordon-laboratories-recalls-monsel-s-solution-with-higher-iron-levels · Updated October 5, 2026 · FDA enforcement record: FDA #D-0338-2019
Cite this page
“Gordon Laboratories recalls Monsel's Solution with higher iron levels.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39377-gordon-laboratories-recalls-monsel-s-solution-with-higher-iron-levels. Based on FDA recall #D-0338-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0338-2019%22&limit=1).
Why it’s dangerous
The solution contains higher levels of iron than labeled, which can cause serious health issues if misused. This superpotent drug is intended for medical use only and requires precise dosing.
Who’s affected
People who have the recalled Monsel's Solution bottles with specific batch numbers and expiration dates are affected. Those using the product for medical purposes are at the highest risk.
How to tell if you have this one
Check for the 8 mL amber glass bottles with one dozen bottles per box. Look for batch numbers 579602, 579604, 579606 (expiring 12/18) or 579609 (expiring 04/19).
- Brand
Gordon Laboratories- Category
Drug
What to do — step by step
Check Product Details
Identify the batch number and expiration date on the bottle to confirm if it's part of the recall.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “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 2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0338-2019 (December 10, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0338-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.