Skip to content
Use caution Drug recall · FDA · Published January 24, 2019

US Compounding Recalls LET Gel 4% Due to Labeling Errors

US Compounding Inc recalls 1,931 syringes of LET Gel 4% because labels lack real lot and expiration dates. Check your syringe now.

🇺🇸 FDA recall #D-0482-2019DrugUS Compounding ›
Take action

Contact the company

Recalling firmUS Compounding Inc1270 Dons Ln · Conway, AR 72032-4753
✎ GovInfoNow plain-language explainer

US Compounding Inc is recalling 1,931 single-use syringes of LET Gel 4% due to labeling errors. The labels are printed with placeholder text for the lot number and expiration date instead of actual values. This makes it impossible to verify the product's identity or shelf life. Read more at govinfonow.com/recall/39230-us-compounding-recalls-let-gel-4-due-to-labeling-errors.

Source Summary by GovInfoNow · govinfonow.com/recall/39230-us-compounding-recalls-let-gel-4-due-to-labeling-errors · Updated October 11, 2026 · FDA enforcement record: FDA #D-0482-2019

Cite this page

“US Compounding Recalls LET Gel 4% Due to Labeling Errors.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/39230-us-compounding-recalls-let-gel-4-due-to-labeling-errors. Based on FDA recall #D-0482-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0482-2019%22&limit=1).

The FDA announced on Jan. 24, 2019, that US Compounding Inc voluntarily recalled LET Gel 4% syringes due to labeling errors where lot and expiration dates were missing or printed incorrectly. Owners should contact the company at 800-718-3588 for information.

How to tell if you have it

  • Brand: US Compounding
  • Product: LET Gel 4% Syringe
  • Description: Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%, 3mL Single Use Syringe, Rx only
  • UPC: 62295501303
  • UPC: 6229550130

The hazard

According to the FDA, the hazard involves labeling errors where labels are missing lot and expiration dates or are printed as Lot# YYYDDYY@XX with a Beyond Use Date of MM/DD/YYY.

Context

GovInfoNow's records show US Compounding Inc has 6 other recalls on record since May 16, 2014. Other recent recalls of similar products include American Regent Levocarnitine Injection Recall (April 16, 2026), Sandoz Focalin XR 5mg Capsules (June 1, 2026), and ICU Medical Recalls Potassium Chloride Injection (Oct. 29, 2025).

How to tell if you have this one

Look for a 3mL single-use syringe labeled as LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%). Check the label for the specific placeholder text 'Lot# YYYDDYY@XX' and 'Beyond Use Date: MM/DD/YYY'. The barcode is 62295501303.

  • Brand
    US Compounding
  • Product
    LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), 3mL Single Use Syringe, Rx only, US
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Your Syringe

    Inspect the label on your syringe for the placeholder lot and expiration date text instead of real numbers.

  2. Contact Your Provider

    If you have this product, contact your healthcare provider or pharmacist to determine if it should be returned or replaced.

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 12 months after the firm started it.

1. Firm started the recall: Jan 24, 201912. FDA classified it Class II: Feb 8, 201923. Published in FDA’s Enforcement Report: Feb 20, 201934. FDA terminated the recall: Jan 24, 2020420192020
  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.

✎ GovInfoNow

Questions people ask

When was this recall issued?

The recall was issued on January 24, 2019.

How many units are affected by this recall?

Approximately 1,931 syringes are included in this recall.

Similar recalls

Latest drug recalls

Keep exploring

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-0482-2019 (January 24, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0482-2019 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