Class II · Moderate risk
Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/…
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
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
Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/…
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL…
Lack Of Assurance Of Sterility.
Class II · Moderate risk
Phenylephrine HCL 100 mcg per mL
Superpotent Drug
Class II · Moderate risk
Doctor Manzanilla Cough & Cold
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
Doctor Manzanilla Allergy & Decongestant Relief
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution
Lack of Assurance of Sterility.
Class II · Moderate risk
Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Class II · Moderate risk
Phenylephrine HCL in 0.9% Sodium Chloride 10 mL
Lack of Sterility Assurance.
Class II · Moderate risk
PHENYLephrine 50 mg in 0.9% Sodium Chloride 250 mL
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
PHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
PHENYLephrine 200 mg in 0.9% Sodium Chloride 250 mL
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
PHENYLephrine 100 mg in 0.9% Sodium Chloride 250 mL Bag
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
PHENYLephrine 10 mg in 0.9% Sodium Chloride 250 mL bag
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride 250 mL Bag
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
PHENYLephrine HCl 25 mg in 0.9% Sodium Chloride 250 mL
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
PHENYLephrine HCl 60 mg in 0.9% Sodium Chloride 250 mL
Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk
PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Class II · Moderate risk
PHENYLephrine HCL in 0.9% Sodium Chloride injectable
Lack of assurance of sterility: Product bags leaking at seam.
Class II · Moderate risk
Phenylephrine 2.5%
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
Phenylephrine HCl all strengths
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk
LIDOCAINE CREAM in all strengths including: 5%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
LTP (Lidocaine 10%, Tetracaine 2%, Phenylephrine 0.5%)
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
MakeSense PHARMA
CGMP Deviations
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