Class III · Low risk
LET Gel
Product Mix-up: Incorrect Product Formulation
Is Tetracaine recalled?
Not under an active recall.
Tetracaine was recalled 38 times in the past — all now closed. Most recent: Nov 9, 2023.
Most common reason: Sterility / contamination (15 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Tetracaine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Tetracaine recalls on record
none so far in 2026; 38 on record, newest first
Class II · Moderate risk
New & Improved Blue Gel Anesthetic
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Class II · Moderate risk
Tetracaine Hydrochloride Ophthalmic Solution
cGMP deviations: Temperature abuse
Class II · Moderate risk
TETRACAINE 1% Tetracaine HCI Injection
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Tetracaine HCl Nasal Solution
CGMP Deviations
Class II · Moderate risk
Profound-PE Dental Gel
CGMP Deviations
Class II · Moderate risk
Profound-PE Dental Gel
CGMP Deviations
Class II · Moderate risk
Profound Dental Gel
CGMP Deviations
Class II · Moderate risk
Profound Dental Gel
CGMP Deviations
Class II · Moderate risk
LET Topical Gel
CGMP Deviations
Class II · Moderate risk
LT Topical Cream
CGMP Deviations
Class II · Moderate risk
BLT Topical Cream
CGMP Deviations
Class II · Moderate risk
Lidocaine/Tetracaine
Superpotent Drug. Lidocaine higher concentration than listed
Class II · Moderate risk
LETS GEL KIT Convenience Pack
Microbial contamination of non-sterile product.
Class II · Moderate risk
OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic
Lack of Assurance of Sterility
Class II · Moderate risk
OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic Single Dose 0.6 mL
Lack of Assurance of Sterility
Class II · Moderate risk
OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic
Lack of Assurance of Sterility
Class II · Moderate risk
OCuSOFT Tetravisc Forte
Lack of Assurance of Sterility
Class II · Moderate risk
Tetcaine (Tetracaine Hydrochloride)
Lack of Assurance of Sterility
Class II · Moderate risk
Altacaine (Tetracaine Hydrochloride)
Lack of Assurance of Sterility
Class II · Moderate risk
LET Gel 4%
Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date and are printed as Lot# YYYDDYY@XX with a Beyond Use Date: MM/DD/YYY.
Class II · Moderate risk
Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream packaged in jars
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Benzocaine 20%
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Benzocaine 20%
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
LIDOCAINE CREAM in all strengths including: 5%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.