Phenylephrine recalls

The FDA has published 122 recalls involving Phenylephrine since 2012. The latest was reported on 6 May 2026. Most were for sterility. SCA Pharmaceuticals 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 recalls122since 2012

Last 12 months1reported

Class I97% of total

Ongoing6latest 6 May 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 1 1Feb 0 1 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 1May 0 0 0Aug 0 0

Severity split

Class I 9 7%Class II 112 92%Class III 1 1%

Why phenylephrine is recalled

Companies

Brands

Phenylephrine Hydrochloride11%
4 WAY11%

By year

202611%
202532%
2024108%
20232218%
20222016%
202154%
20191512%
201876%
20171411%
201665%

Ongoing phenylephrine recalls

6 active

Reported	Class	Recall	Company	Reason	Where
6 May 2026Drug	CLASS II	Phenylephrine Hydrochloride Injectable Solution, 40mg recalled	Wells Pharma of Houston	Manufacturing (CGMP) Deviations	Nationwide
30 Apr 2025Drug	CLASS II	PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg recalled	Denver Solutions	Sterility	Nationwide
26 Feb 2025Drug	CLASS I	Phenylephrine HCl Injection, USP 100 mg/ (10 mg/mL) vials recalled	Provepharm	Particulate Matter	Nationwide
10 Apr 2024Drug	CLASS II	Phenylephrine HCl, 1000 mcg/ Total Volume per syringe, Intravenous recalled	SSM Health Care St. Louis	Sterility	MO
24 May 2023Drug	CLASS II	PHENYLephrine HCl Injection, 1 mg per (100 mcg/mL) recalled	Apollo Care	Sterility	MO
17 Jul 2013Drug	CLASS II	Phenylephrine 1 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide

All phenylephrine recalls, newest first

122 total

Reported	Class	Recall	Company	Reason	Where
6 May 2026Drug	CLASS II	Phenylephrine Hydrochloride Injectable Solution, 40mg recalled	Wells Pharma of Houston	Manufacturing (CGMP) Deviations	Nationwide
30 Apr 2025Drug	CLASS II	PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg recalled	Denver Solutions	Sterility	Nationwide
26 Feb 2025Drug	CLASS I	Phenylephrine HCl Injection, USP 100 mg/ (10 mg/mL) vials recalled	Provepharm	Particulate Matter	Nationwide
8 Jan 2025Drug	CLASS II	phenylephrine in 0.9% Sodium Chloride Inj, 1mg per (100 mcg/mL) recalled	Hikma Injectables USA	Sterility	Nationwide
29 May 2024Drug	CLASS I	Phenylephrine in 0.9% Sodium Chloride Injection recalled	Hikma Injectables USA	Labeling Errors	5 states
10 Apr 2024Drug	CLASS II	Phenylephrine HCl, 1000 mcg/ Total Volume per syringe, Intravenous recalled	SSM Health Care St. Louis	Sterility	MO
3 Apr 2024Drug	CLASS II	PHENYLephrine HCl 500 mcg/ in 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
3 Apr 2024Drug	CLASS II	PHENYLephrine HCl 500 mcg/ in 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
3 Apr 2024Drug	CLASS II	PHENYLephrine HCl 1000 mcg recalled by SCA Pharmaceuticals	SCA Pharmaceuticals	Sterility	Nationwide
3 Apr 2024Drug	CLASS II	PHENYLephrine HCl 800 mcg/ in 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
3 Apr 2024Drug	CLASS II	PHENYLephrine HCl 800 mcg/ in 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
3 Apr 2024Drug	CLASS II	PHENYLephrine HCl 400 mcg/ in 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
3 Apr 2024Drug	CLASS II	PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection recalled	SCA Pharmaceuticals	Sterility	Nationwide
3 Apr 2024Drug	CLASS II	PHENYLephrine HCl 5000 mcg recalled by SCA Pharmaceuticals	SCA Pharmaceuticals	Sterility	Nationwide
11 Oct 2023Drug	CLASS II	PHENYLephrine in 0.9% sodium chloride, 1,000 mcg recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
11 Oct 2023Drug	CLASS II	PHENYLephrine in 0.9 sodium chloride, 400 mcg/, (40 mcg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
11 Oct 2023Drug	CLASS II	PHENYLephrine in 0.9 sodium chloride, 800 mcg/, (80 mcg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023Drug	CLASS II	PHENYLephrine, added to 0.9% sodium chloride, 40mg/ (160mcg/mL), IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
6 Sep 2023Drug	CLASS II	PHENYLephrine, added to 0.9% sodium chloride, 10mg/ (40mcg/mL), IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	PHENYLephrine, 10mg/ added to 0.9% sodium chloride, 40mcg/mL, IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	PHENYLephrine in 0.9 sodium chloride, 400 mcg /, (40 mcg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	PHENYLephrine 20mg/ added to 0.9% sodium chloride, IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	PHENYLephrine in 0.9% sodium chloride, 1000 mcg recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	PHENYLephrine, 40mg/, added to 0.9% sodium chloride, IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	phenylephrine, 25mg added to 0.9% sodium chloride, IV recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	PHENYLephrine in 0.9 sodium chloride, 800 mcg /, (80 mcg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
24 May 2023Drug	CLASS II	PHENYLephrine HCl Injection, 1 mg per (100 mcg/mL) recalled	Apollo Care	Sterility	MO
15 Mar 2023Drug	CLASS II	Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride IV recalled	Denver Solutions	Manufacturing (CGMP) Deviations	Nationwide
15 Mar 2023Drug	CLASS II	Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium recalled	Denver Solutions	Manufacturing (CGMP) Deviations	Nationwide
8 Mar 2023Drug	CLASS II	Phenylephrine HCl Injection, USP, 0.8 mg 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.