Class II · Moderate risk
EPINEPHrine
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Is Epinephrine recalled?
Yes — there is an active recall. 19 ongoing FDA recalls mention Epinephrine (118 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Epinephrine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Epinephrine recalls on record
none so far in 2026; 118 on record, newest first
Class II · Moderate risk
EPINEPHrine 4mg/250mL added to 0.9% sodium chloride
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
EPINEPHrine added to 0.9% sodium chloride
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
EPINEPHrine added to dextrose 5%
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
EPINEPHrine added to dextrose 5%
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk
EPINEPHrine added to dextrose 5%
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class III · Low risk
Epinephrine Professional EMS
Labeling; Incorrect NDC number on outer carton of product.
Class II · Moderate risk
Maximum Zone2 Topical Analgesic
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
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
Glycerin/Lidocaine Hcl/Epinephrine 31%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Epi-Caine
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class I · High risk
Epinephrine
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Class I · High risk
Epinephrine
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Class II · Moderate risk
Sensorcaine-MPF
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Class II · Moderate risk
Sensorcaine
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Class II · Moderate risk
Sensorcaine
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Class II · Moderate risk
LIDOCAINE EPINEPHRINE BUFFERED 2%/1:1000 Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
EPINEPHrine Injection
Lack of Assurance of Sterility
Class II · Moderate risk
EPINEPHrine Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Epinephrine Injection
Lack of Assurance of Sterility
Class II · Moderate risk
EPINEPHrine Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine 1%/Epinephrine 1:100
Lack of assurance of sterility.
Class II · Moderate risk
Epinephrine
cGMP deviations: Temperature abuse
Class II · Moderate risk
Xylocaine + Epinephrine
cGMP deviations: Temperature abuse
Class II · Moderate risk
Xylocaine + Epinephrine
cGMP deviations: Temperature abuse
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