Class I · High risk
Epinephrine Injection
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
Is Epinephrine recalled?
Yes — there is an active recall. 19 ongoing FDA recalls mention Epinephrine (118 total). Check the affected lots below.
Most common reason: Sterility / contamination (55 of these recalls)
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 in 2026
7 initiated in 2026, 118 in total — newest first
Class III · Low risk
Epinephrine Injection
Failed Impurities/Degradations Specifications
Class II · Moderate risk
EPINEPHRINE Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Maximum
Stability Data Does Not Support Expiry Date.
Class II · Moderate risk
Lidocaine HCI 2% and Epinephrine 1:100
Defective container: cracked/broken cartridges
Class II · Moderate risk
2% Xylocaine DENTAL with Epinephrine 1:100
Defective container: cracked/broken cartridges
Class II · Moderate risk
R.E.C.K.
Presence of Particulate Matter
Class II · Moderate risk
Vial Label: Epinephrine Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Epinephrine Lidocaine HCL
Sub-Potent Drug: Subpotent assay results during stability testing.
Class II · Moderate risk
LIDOcaine HCL Sterile Injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
BUPIVAcaine HCL Sterile injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class I · High risk
Adrenalin Chloride Solution
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Class II · Moderate risk
EPINEPHrine 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
Lidocaine HCL Injection
Subpotent Drug: reduced efficacy for epinephrine
Class II · Moderate risk
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL…
Lack of Assurance of Sterility
Class II · Moderate risk
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL…
Lack of Assurance of Sterility
Class III · Low risk
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free
Out of specification for assay
Class II · Moderate risk
Adrenalin (epinephrine)
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Class III · Low risk
LET Gel
Product Mix-up: Incorrect Product Formulation
Class III · Low risk
Epinephrine-Lidocaine HCl
Subpotent: Failing Test Results for Epinephrine
Class II · Moderate risk
EPINEPHrine added to dextrose 5%
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
EPINEPHrine added to 0.9% sodium chloride
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
EPINEPHrine
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
EPINEPHrine 8mg/250ml added to dextrose 5%
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
EPINEPHrine added to dextrose 5%
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
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