Class II · Moderate risk
PHENYLephrine 20mg/250ml added to 0.9% sodium chloride
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Is Phenylephrine recalled?
Yes — there is an active recall. 17 ongoing FDA recalls mention Phenylephrine (292 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Phenylephrine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Phenylephrine recalls on record
none so far in 2026; 292 on record, newest first
Class II · Moderate risk
PHENYLephrine
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Class III · Low risk
Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag
Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Class II · Moderate risk
PHENYLephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
phenylephrine 50 mg added to 0.9% sodium chloride 250 mL*
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
PHENYLephrine 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
PHENYLephrine 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
PHENYLephrine 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
PHENYLephrine 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 I · High risk
G-Supress DX
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Class II · Moderate risk
Phenylephrine HCl in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl 20 mg
CGMP DEVIATIONS
Class II · Moderate risk
Phenylephrine HCl 40 mg
CGMP DEVIATIONS
Class II · Moderate risk
Phenylephrine HCl 1mg per 10mL
CGMP DEVIATIONS
Class II · Moderate risk
Phenylephrine HCl 0.5 mg per 5 mL
CGMP DEVIATIONS
Class II · Moderate risk
Phenylephrine Hydrochloride Injection
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Phenylephrine Hydrochloride Injection
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Phenylephrine Hydrochloride Injection
CGMP Deviations: recalling drug products following an FDA inspection.
Class III · Low risk
NDC 0363-6171-09 Walgreens Sinus Pressure
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Class II · Moderate risk
LIDOCAINE/PHENYLEPHRINE PF SYR 1%/1.5% 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
Phenylephrine HCl Injection
Lack of Assurance of Sterility
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