LET Gel Topical Anesthetic Recalled Due to Incorrect Product Formulation
Right Value Drug Stores is recalling LET Gel topical anesthetic syringes nationwide due to incorrect product formulation. Patients should not use affected syringes and should consult their healthcare provider.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III recall for an incorrect product formulation with no reported illnesses or injuries. Class III recalls are typically low to moderate severity and are often voluntary precautionary measures.
Plain-English summary
Right Value Drug Stores, LLC is recalling LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel) in 3mL single-use syringes distributed in 10-pack boxes. The recall is due to an incorrect product formulation.
The product was distributed nationwide. Approximately 190 syringes with lot number 09202023@7 (expiration date March 18, 2024) were affected. Healthcare facilities and patients who received this product may have been impacted.
Do not use the affected syringes. If you have received or used this product, contact your healthcare provider or dentist immediately to discuss your treatment. Return any unused product to the pharmacy where it was obtained.
The recalled product
- Product
- LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL syringe, 10/pack, Rx only, Carie Boyd Pharmaceuticals, 8400 Esters Blvd, Ste# 190, Irving, TX 75063, NDC73271-1003-1
- Category
- Drug — Topical Anesthetic
- Affected units
- 190
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)
- Lot#: 09202023@7
- Exp 03/18/2024
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · product mix up
See all →- HighAripiprazole 30mg bottle contained voriconazole 50mg tablets instead
FDA (Drugs) · 2026-06-24
- HighOmeprazole capsule bottle contained a foreign divalproex sodium tablet
FDA (Drugs) · 2025-07-23
- HighLisinopril and hydrochlorothiazide bottle contained a foreign antiretroviral tablet
FDA (Drugs) · 2025-07-23
- HighKWIK-STICK Quality Control Kit for Culture Media Swab Mix-Up
FDA (Devices) · 2025-06-18
- HighStryker 3.0MM Neuro Precision Head Recalled for Package Labeling Mismatch
FDA (Devices) · 2025-01-29
Similar recalls
- ModerateLET Topical Gel drug recall for CGMP deviations
FDA (Drugs) · 2022-02-02
- ModerateUS Compounding Recalls LET Gel 4% Syringes Due to Missing Lot and Expiration Dates
FDA (Drugs) · 2019-02-20
- LowEdge Pharma Recalls Epinephrine/Lidocaine Ophthalmic Solution Due to Labeling Errors
FDA (Drugs) · 2021-03-24
- ModerateRight Value Recalls Glutathione Injectable Due to Incorrect Gas Formulation
FDA (Drugs) · 2015-01-14
- SevereCantrell Drug Recalls Lidocaine HCl Syringes Due to Sterility Concerns
FDA (Drugs) · 2016-12-21
- ModeratePharmedium Recalls Fentanyl Citrate Syringes Due to Stability Data Concerns
FDA (Drugs) · 2016-10-19