Class II · Moderate risk
Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution
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 HCl 1 mg/10 mL
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk
Phenylephrine HCl Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5%…
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Phenylephrine HCI Injection
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Class II · Moderate risk
Pre-Op Pledget Soln + Tetracaine
Lack of Assurance of Sterility
Class II · Moderate risk
Pre-Op Pledget Soln
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCI
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCI100mcg/mL in 0.9% sodium Chloride 10ml fill in a 10mL BD syringe
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCI 40mg/250 mL in 0.9% Sodium Chloride 250 mL bag
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine 40 mcg/mL injection in 0.9% Sodium Chloride 10 mL syringe
Lack of Assurance of Sterility
Class I · High risk
PHENYLephrine 1 mg/10 mL
Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10 mL (40 mcg/ml) on the light protective overwrap of each syringe.
Class II · Moderate risk
All phenylephrine Products
Lack of Processing Controls
Class II · Moderate risk
Phenylephrine 500mcg/mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Tropicamide 1%/Phenylephrine 2.5%
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
Tropicamide 0.5%/ Phenylephrine 5%
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
Phenylephrine PF Sterile Solution
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
Phenylephrine PF
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
Phenylephrine
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
Phenylephrine 10% PF Ophthalmic Solution
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
Phenylephrine 1.5%/ Lidocaine 1%
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
Phenylephrine
Stability data does not support expiry.
Class II · Moderate risk
PHENYLephrine HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
PHENYLephrine HCl
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
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