CLASS II Drug recall · Reported 8 Mar 2023 · FDA Enforcement Report

Phenylephrine HCl Injection, USP, 0.4 mg recalled

Nephron Sterile Compounding Center is recalling Phenylephrine HCl Injection, USP, 0.4 mg/ (40 mcg/mL) Single-Dose Vial, distributed nationwide in the US. The recall was initiated on 22 Feb 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: PE2028, Exp. 06/15/2023

Quantity recalled31,500 vials

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0360-2023
FDA event ID: 91749
Recalling firm: Nephron Sterile Compounding Center, West Columbia, SC
Classification: Class II
Status: Terminated
Recall initiated: 22 Feb 2023
FDA classified: 27 Feb 2023
Reported: 8 Mar 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Cold & Cough Medicine

Timeline

22 Feb 2023	Recall initiated by company
27 Feb 2023	Classified by FDA	+5 days
8 Mar 2023	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-305-10.

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

Lots: PE2028, Exp. 06/15/2023

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

7 other products · FDA event 91749

This product is part of a recall event; the main page for the event is Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled.

Reported	Class	Recall	Company	Reason	Where
8 Mar 2023	CLASS II	Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023	CLASS II	Phenylephrine HCl Injection, USP, 1 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023	CLASS II	Phenylephrine HCl in 0.9% Sodium Chloride Injection recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023	CLASS II	Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023	CLASS II	Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023	CLASS II	Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023	CLASS II	Phenylephrine HCl Injection, USP, 0.8 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide

More recalls from Nephron Sterile Compounding Center

All 73

Reported	Class	Recall	Company	Reason	Where
19 Mar 2025Drug	CLASS II	Sodium Chloride Injection 9%, USP, Single-Dose IV recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023Drug	CLASS II	Phenylephrine HCl Injection, USP, 0.8 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023Drug	CLASS II	Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023Drug	CLASS II	Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023Drug	CLASS II	Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide

Other Phenylephrine recalls

All 122

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