The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0482-2019·Announced 2019-02-20

US Compounding Recalls LET Gel 4% Syringes Due to Missing Lot and Expiration Dates

US Compounding Inc is recalling 1,931 syringes of LET Gel 4% because the labels are missing specific lot and expiration dates.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the specific hazard is a labeling error (missing lot and expiration dates) without reported injuries or illnesses, fitting the 'Moderate' criteria for minor labeling errors.

Plain-English summary

US Compounding Inc is recalling 1,931 syringes of LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), 3mL Single Use Syringe. The product is prescription-only and was distributed nationwide in the USA.

The recall was initiated due to labeling errors where the labels are missing the specific lot and expiration date. Instead, the labels are printed with placeholder text: Lot# YYYDDYY@XX and Beyond Use Date: MM/DD/YYYY.

Consumers and healthcare providers should stop using the affected syringes and contact US Compounding Inc at 800-718-3588 for instructions on how to return the product.

The recalled product

Product
LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), 3mL Single Use Syringe, Rx only, US Compounding, 1270 Don's Lane, Conway, AR, 800-718-3588, Barcode 62295501303.
Manufacturer
US Compounding Inc
Category
Drug — Topical Anesthetic
Hazard
Affected units
1,931

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Labeled as Lot# YYYDDYY@XX
  • Beyond Use Date: MM/DD/YYYY.

Distribution

Distributed nationwide across the United States.

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