Class II · Moderate risk
norepinephrine Bitartrate
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Is Norepinephrine recalled?
Yes — there is an active recall. 5 ongoing FDA recalls mention Norepinephrine (72 total). Check the affected lots below.
Most common reason: Sterility / contamination (52 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Norepinephrine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Norepinephrine recalls in 2026
2 initiated in 2026, 72 in total — newest first
Class II · Moderate risk
norepinephrine Bitartrate
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class II · Moderate risk
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
Norepinephrine Bitartrate in 5% Dextrose Injection
Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
Class II · Moderate risk
norepinephrine
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
NORepinephrine 4 mg/250 mL added to 0.9% sodium chloride 16 mcg/mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
Norepinephrine 32 mg per 250 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine 16 mg per 250 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine 8 mg per 250 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine 4 mg per 250 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
NORepinephrine 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
NORepinephrine 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
NORepinephrine 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
NORepinephrine 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
norepinephrine 4 mg added to dextrose 5% 250 mL*
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
Norepinephrine Bitartrate Injection
Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
Class II · Moderate risk
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag
CGMP Deviations
Class II · Moderate risk
Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
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