Class II · Moderate risk
Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag
Lack of sterility assurance.
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 20 mg NS 250 mL bag
Lack of sterility assurance.
Class II · Moderate risk
Phenylephrine 0.8 mg/10 mL NS
Lack of sterility assurance.
Class II · Moderate risk
Phenylephrine 1 mg/mL Injection
Lack of sterility assurance.
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl
Lack of Assurance of Sterility
Class I · High risk
Phenylephrine HCl
Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".
Class II · Moderate risk
Phenylephrine 30 mg added to NS 250 mL Bag
Lack of assurance of sterility
Class II · Moderate risk
Phenylephrine 25 mg added to NS 250 mL Bag
Lack of assurance of sterility
Class II · Moderate risk
Rhinall Nasal Decongestant Nasal Spray
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Rhinall (phenylephrine hydrochloride)
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk
PHENYLephrine 10 mg
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
PHENYLephrine 20 mg
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
PHENYLephrine 40 mg
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
100 mcg / mL Phenylephrine HCl
Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Class II · Moderate risk
Phenylephrine HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
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