Phenylephrine recalls

The FDA has published 20 recalls involving Phenylephrine since 2013. The latest was reported on 26 Feb 2025. Most were for sterility. Nephron Sterile Compounding Center has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls20since 2013

Last 12 months0reported

Class I15% of total

Ongoing2latest 26 Feb 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 1 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 1 5%Class II 18 90%Class III 1 5%

Why phenylephrine is recalled

Companies

Brands

4 Way15%
Phenylephrine Hydrochloride15%

By year

202515%
2023735%
2022945%
202115%
2013210%

Ongoing phenylephrine recalls

2 active

Reported	Class	Recall	Company	Reason	Where
26 Feb 2025Drug	CLASS I	Phenylephrine HCl Injection, USP 100 mg/ (10 mg/mL) vials recalled	Provepharm	Particulate Matter	Nationwide
24 May 2023Drug	CLASS II	PHENYLephrine HCl Injection, 1 mg per (100 mcg/mL) recalled	Apollo Care	Sterility	MO

All phenylephrine recalls, newest first

20 total

Reported	Class	Recall	Company	Reason	Where
26 Feb 2025Drug	CLASS I	Phenylephrine HCl Injection, USP 100 mg/ (10 mg/mL) vials recalled	Provepharm	Particulate Matter	Nationwide
24 May 2023Drug	CLASS II	PHENYLephrine HCl Injection, 1 mg per (100 mcg/mL) recalled	Apollo Care	Sterility	MO
8 Mar 2023Drug	CLASS II	Phenylephrine HCl Injection, USP, 8 mg/ (80 mcg/mL) Single-Dose Vial recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023Drug	CLASS II	Phenylephrine Hydrochloride Injection, USP, 50 mg/ (10 mg/mL) recalled	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Phenylephrine Hydrochloride Injection, USP 100 mg/ (10 mg/mL) recalled	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Phenylephrine HCl Injection, USP, 4 mg/ (40 mcg/mL) Single-Dose Vial recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023Drug	CLASS II	Phenylephrine Hydrochloride Injection, USP 10 mg/mL recalled	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Phenylephrine HCl Injection, USP, 1 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022Drug	CLASS II	Phenylephrine HCl Injection, USP, 8 mg/ (80 mcg/mL)syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022Drug	CLASS II	Phenylephrine HCl Injection, USP, 1 mg/ (100 mcg/mL) syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide

Should you stop taking Phenylephrine?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.