Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0437-2022·Announced 2022-02-02

LET Topical Gel drug recall for CGMP deviations

Edge Pharma is recalling 26,917 syringes of LET Topical Gel nationwide due to current Good Manufacturing Practice (CGMP) deviations. The recall was initiated voluntarily in December 2021.

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: This is an FDA Class II recall for CGMP deviations. The source text does not report any illnesses, injuries, or deaths, and the hazard is manufacturing process deficiency rather than a direct safety risk. Per the rubric, manufacturing/quality issues without reported harm and no stated illness/injury reports are typically classified as Moderate (2).

Plain-English summary

Edge Pharma, LLC is recalling LET Topical Gel (Lidocaine HCL / Epinephrine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per syringe, Single Dose Syringe for Topical Use) with NDC 05446-0607-01 due to current Good Manufacturing Practice (CGMP) deviations.

Approximately 26,917 syringes were distributed nationwide. The affected product was manufactured with lot codes issued between July 2021 and October 2021, with distribution dates ranging from December 2021 through March 2022.

The recall is classified as FDA Class II and was initiated voluntarily by the firm on December 6, 2021, based on a press release. The recall has been terminated as of June 7, 2023.

Consumers and healthcare providers in possession of affected syringes should stop use and contact Edge Pharma, LLC for further instructions.

The recalled product

Product: LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per syringe, Single Dose Syringe for Topical Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT, NDC 05446-0607-01
Manufacturer: Edge Pharma, LLC
Category: Drug — Topical Anesthetic
Hazard: cgmp-deviations
manufacturing-deficiency
Affected units: 26,917

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 (11)

07-2021-12@6 12-09-2021
07-2021-19@7 12-16-2021
07-2021-26@5 12-23-2021
08-2021-02@8 12-30-2021
08-2021-09@10 01-06-2022
08-2021-13@6 01-10-2022
08-2021-18@4 01-15-2022
08-2021-24@8 01-21-2022
08-2021-30@5 01-27-2022
09-2021-07@11 02-04-2022
09-2021-13@5 02-10-2022 & 10-2021-04@9 03-03-2022.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 56 recalled by Edge Pharma, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 56 products in this recall →

Same manufacturer · Edge Pharma, LLC

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