Class II · Moderate risk
PHENYLephrine HCl
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: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Class II · Moderate risk
PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9%
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg…
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk
Phenylephrine Hydrochloride Ophthalmic Solution
Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
Class II · Moderate risk
Cyclopentolate HCl 1%
Lack of Assurance of Sterility
Class II · Moderate risk
Cyclopentolate HCl 1%
Lack of Assurance of Sterility
Class II · Moderate risk
Cyclopentolate HCl 1%
Lack of Assurance of Sterility
Class II · Moderate risk
Cyclopentolate HCl 1%
Lack of Assurance of Sterility
Class II · Moderate risk
Cyclopentolate HCl 1%
Lack of Assurance of Sterility
Class II · Moderate risk
PHENYLephrine HCl in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
PHENYLephrine HCl 1.5%
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl 1.5%
Lack of Assurance of Sterility
Class II · Moderate risk
S-Lidocaine HCL 1% / Phenylephrine1.5%
Lack of Assurance of Sterility
Class II · Moderate risk
Neogen-D
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
Tusslin
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
Gencontuss
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
Phenylephrine HCL 100 Mcg/Ml in Nacl 0.9% Syr
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCL PF INJ in 0.9% Sodium Chloride
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Class II · Moderate risk
Lidocaine 0.5%/Phenylephrine 0.75% P.F. INJ
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Class II · Moderate risk
Anu-Med brand of Hemorrhoidal Suppositories
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Hemorrhoidal Suppositories
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
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