Fagron LETS Gel Kit Convenience Pack: Microbial Contamination Hazard
Fagron recalls LETS Gel Kit Convenience Packs (for 100mL preparation) due to microbial contamination in non-sterile product. This prescription compounding kit contains lidocaine, ephinephrine, and other ingredients. Discard all affected kits immediately.
Stop using this now
Microbial contamination of non-sterile product.
Contact the company
What happened, in plain English
Fagron is recalling LETS Gel Kit Convenience Packs that contain prescription-strength numbing gel ingredients. The product has been found to have microbial contamination, which could cause infection if used improperly. Read more at govinfonow.com/recall/37774-fagron-lets-gel-kit-convenience-pack-microbial-contamination-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/37774-fagron-lets-gel-kit-convenience-pack-microbial-contamination-hazard · Updated October 5, 2026 · FDA enforcement record: FDA #D-0533-2020
Cite this page
“Fagron LETS Gel Kit Convenience Pack: Microbial Contamination Hazard.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37774-fagron-lets-gel-kit-convenience-pack-microbial-contamination-hazard. Based on FDA recall #D-0533-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0533-2020%22&limit=1).
Why it’s dangerous
The product contains non-sterile ingredients that can become contaminated with harmful microorganisms. When used for medical procedures, this contamination could lead to infections in the body, especially in sensitive areas like the skin or mucous membranes.
Who’s affected
Prescription users who have the LETS Gel Kit Convenience Packs (for preparing 100mL of local anesthetic gel) are affected. Patients using this kit for medical procedures are at risk of infection.
How to tell if you have this one
Check for the LETS Gel Kit Convenience Pack with NDC code 51552-1539-1 or similar lot numbers listed in the recall notice. The product is for prescription compounding only and contains lidocaine, ephinephrine, and other medications.
- Brand
Fagron- Category
Drug
What to do — step by step
Discard Immediately
Remove all affected LETS Gel Kit Convenience Packs from your home and dispose of them safely.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months 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-0533-2020 (October 31, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0533-2020 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.