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Stop using now Drug recall · FDA · Published July 19, 2019

Gordon Laboratories Recalls Monsel's Solution Due to Contamination

Gordon Laboratories recalls 8 mL bottles of Monsel's Solution due to microbial contamination and incorrect iron content. Check your batch numbers.

🇺🇸 FDA recall #D-1528-2019DrugGordon Laboratories ›
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Recalling firmDercher Enterprises, Inc., DBA Gordon Laboratories6801 Ludlow St · Upper Darby, PA 19082-2408
✎ GovInfoNow plain-language explainer

Gordon Laboratories is recalling MONSEL'S (Ferric Subsulfate) Solution, an 8 mL amber glass bottle, because it contains microbial contamination and has out-of-specification iron levels. The affected product was distributed nationwide in the USA. No remedy or return instructions are currently listed in the record. Read more at govinfonow.com/recall/38262-gordon-laboratories-recalls-monsel-s-solution-due-to-contamination.

Source Summary by GovInfoNow · govinfonow.com/recall/38262-gordon-laboratories-recalls-monsel-s-solution-due-to-contamination · Updated October 11, 2026 · FDA enforcement record: FDA #D-1528-2019

Cite this page

“Gordon Laboratories Recalls Monsel's Solution Due to Contamination.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/38262-gordon-laboratories-recalls-monsel-s-solution-due-to-contamination. Based on FDA recall #D-1528-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1528-2019%22&limit=1).

The FDA announced on July 19, 2019, that Dercher Enterprises, Inc., DBA Gordon Laboratories is recalling MONSEL'S Solution due to microbial contamination and out-of-specification iron content. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Gordon Laboratories
  • Product: MONSEL'S (Ferric Subsulfate) Solution
  • Size: 8 mL amber glass bottle
  • Packaging: One dozen bottles with applicators per box
  • NDC: 10481-0112-8
  • Batch #: 579634, 579635
  • Expiration: 5/2020
  • Quantity: 277 boxes

The hazard

FDA analysis revealed microbial contamination in addition to high out of specification results for iron content. The product is classified as a superpotent drug.

Context

GovInfoNow's records show Dercher Enterprises, Inc., DBA Gordon Laboratories has one other recall on record since April 12, 2024: the Gordofilm Wart Remover Recall for cGMP deviations. Other recent recalls of similar products include the Blaine Labs Revitaderm Gel Recall (April 8, 2026), the Trifluent Pharma Wound Care Gel Recall (April 8, 2026), and the Blaine Labs Revitaderm Wound Gel Recall (April 8, 2026).

How to tell if you have this one

Look for an 8 mL amber glass bottle of MONSEL'S (Ferric Subsulfate) Solution packaged with applicators. Check the box for Batch numbers 579634 or 579635 and an expiration date of 5/2020. The National Drug Code (NDC) is 10481-0112-8.

  • Brand
    Gordon Laboratories
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Stop using the product

    Do not use any bottles matching the recalled batch numbers due to contamination risks.

  2. Check your inventory

    Verify if you have bottles with Batch #579634 or 579635 and NDC 10481-0112-8.

  3. Contact your provider

    Speak with your healthcare provider or pharmacist for guidance on replacement or disposal, as specific remedy details are not provided in the record.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

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 4.1 years after the firm started it.

1. Firm started the recall: Jul 19, 201912. FDA classified it Class II: Jul 25, 201923. Published in FDA’s Enforcement Report: Jul 31, 201934. FDA terminated the recall: Aug 14, 2023420192023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. 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-1528-2019 (July 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1528-2019 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA