Class II · Moderate risk
PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
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 HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Tropi-Phen
Lack of Assurance of Sterility
Class II · Moderate risk
TPC Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial
Lack of Assurance of Sterility
Class II · Moderate risk
Tropi-Phen
Lack of Assurance of Sterility
Class II · Moderate risk
PHENYLephrine in 0.9% sodium chloride
Lack of assurance of sterility:
Class II · Moderate risk
PHENYLephrine in 0.9 sodium chloride
Lack of assurance of sterility:
Class II · Moderate risk
PHENYLephrine in 0.9 sodium chloride
Lack of assurance of sterility:
Class III · Low risk
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine -…
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Class II · Moderate risk
PHENYLephrine added to 0.9% sodium chloride 50 mg/250mL
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
PHENYLephrine
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
PHENYLephrine added to 0.9% sodium chloride
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
PHENYLephrine
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
PHENYLephrine 1
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
PHENYLephrine in 0.9 sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
PHENYLephrine in 0.9 sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
PHENYLephrine in 0.9% sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
PHENYLephrine 1
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
phenylephrine 50 mg added to 0.9% sodium chloride 250mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
PHENYLephrine
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
phenylephrine
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
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