Class II · Moderate risk
Phenylephrine HCl 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 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 1 mg/mL
Lack of assurance of sterility.
Class II · Moderate risk
Phenylephrine 1 mg/mL
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
Phenylephrine HCl Injection in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Coated Phenylephrine HCl 5mg Tablet
CGMP Deviations
Class II · Moderate risk
Phenylephrine HCl 5 mg Tablet
CGMP Deviations
Class II · Moderate risk
APAP 500 mg Phenyl HCl 5mg tablet
CGMP Deviations
Class II · Moderate risk
APAP 325 mg/Phenylephrine HCl
CGMP Deviations
Class II · Moderate risk
Coated APAP 325 mg Phenyl HCl 5 mg tablet
CGMP Deviations
Class II · Moderate risk
Kramer Novis Tusicof Caplet
CGMP Deviations
Class II · Moderate risk
Zee Cold Tabs
CGMP Deviations
Class II · Moderate risk
4-Component Cold Tabs
CGMP Deviations
Class II · Moderate risk
3-Component Cold Tabs
CGMP Deviations
Class II · Moderate risk
Leader Nasal Decongestant PE
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Sinus Relief Headache/Nasal
cGMP deviations
Class II · Moderate risk
Sinus Relief
cGMP deviations
Class II · Moderate risk
SINUS DECONGESTANT Nasal Decongestant
cGMP deviations
Class II · Moderate risk
Cetafen Cough & Cold Cough & Cold Relief
cGMP deviations
Class II · Moderate risk
Pain & Sinus Reliever Pain Reliever/Nasal Decongestant
cGMP deviations
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