Class II · Moderate risk
CONGESTAID II Nasal Decongestant
cGMP deviations
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
Dilotab II
cGMP deviations
Class II · Moderate risk
SINU-PHEN PLUS sinus pain and congestion tabs
cGMP deviations
Class II · Moderate risk
COLD TERMINATOR decongestant/cold relief
cGMP deviations
Class II · Moderate risk
Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant
cGMP deviations
Class II · Moderate risk
Headache & Congestion Sinus Relief
cGMP deviations
Class II · Moderate risk
Cold Relief
cGMP deviations
Class II · Moderate risk
Cold Relief Severe Pain/Cough
cGMP deviations
Class II · Moderate risk
Multi Symptom Cold Relief
cGMP deviations
Class II · Moderate risk
Chloresin
cGMP deviations
Class II · Moderate risk
AERO TAB Cold Relief
cGMP deviations
Class II · Moderate risk
Class II · Moderate risk
Nasal & Sinus Decongestant
cGMP deviations
Class II · Moderate risk
Lidocaine HCl/Phenylephrine HCl Nasal Solution
CGMP Deviations
Class II · Moderate risk
Profound-PE Dental Gel
CGMP Deviations
Class II · Moderate risk
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl/Tropicamide
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl/Lidocaine
Lack of Assurance of Sterility
Class II · Moderate risk
PHENYLephrine
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 0.5 mg/5mL
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
PHENYLephrine HCl
Lack of Assurance of Sterility
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