CLASS II Drug recall · Reported 11 Jul 2018 · FDA Enforcement Report

Phenylephrine HCL 50 mg in 0.9% Sodium Chloride Bag recalled

SCA Pharmaceuticals is recalling Phenylephrine HCL 50 mg in 0.9% Sodium Chloride Bag (200 mcg/mL), SCA Pharmaceuticals, distributed nationwide in the US. The recall was initiated on 14 Jun 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 20180329@2, Exp 06/27/2018

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-0904-2018
FDA event ID: 80303
Recalling firm: SCA Pharmaceuticals, Windsor, CT
Classification: Class II
Status: Terminated
Recall initiated: 14 Jun 2018
FDA classified: 2 Jul 2018
Reported: 11 Jul 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Cold & Cough Medicine

Timeline

14 Jun 2018	Recall initiated by company
2 Jul 2018	Classified by FDA	+18 days
11 Jul 2018	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: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.

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 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT

Where it was distributed

Product was distributed throughout the United States.

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.

Which lots are affected?

Lot # 20180329@2, Exp 06/27/2018

Where was it sold?

Product was distributed throughout the United States.

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

11 other products · FDA event 80303

This product is part of a recall event; the main page for the event is Norepinephrine Bitartrate 8 mg (32 mcg/mL) recalled.

Reported	Class	Recall	Company	Reason	Where
11 Jul 2018	CLASS II	Norepinephrine Bitartrate 8 mg (32 mcg/mL) recalled	SCA Pharmaceuticals	Sterility	Nationwide
11 Jul 2018	CLASS II	Diltiazem HCL 1 mg/mL in 0.9% Sodium Chloride bag recalled	SCA Pharmaceuticals	Sterility	Nationwide
11 Jul 2018	CLASS II	Phenylephrine HCL 10 mg in 0.9% Sodium Chloride Bag recalled	SCA Pharmaceuticals	Sterility	Nationwide
11 Jul 2018	CLASS II	Phenylephrine HCL 20 mg in 0.9% Sodium Chloride Bag recalled	SCA Pharmaceuticals	Sterility	Nationwide
11 Jul 2018	CLASS II	Morphine Sulfate 1 mg/mL (preservative free recalled	SCA Pharmaceuticals	Sterility	Nationwide
11 Jul 2018	CLASS II	Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
11 Jul 2018	CLASS II	Norepinephrine Bitartrate 4 mg (16 mcg/mL) recalled	SCA Pharmaceuticals	Sterility	Nationwide
11 Jul 2018	CLASS II	Norepinephrine Bitartrate 16 mg (64 mcg/mL) recalled	SCA Pharmaceuticals	Sterility	Nationwide
11 Jul 2018	CLASS II	Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL recalled	SCA Pharmaceuticals	Sterility	Nationwide
11 Jul 2018	CLASS II	Phenylephrine HCL 40 mg in 0.9% Sodium Chloride Bag recalled	SCA Pharmaceuticals	Sterility	Nationwide
11 Jul 2018	CLASS II	Phenylephrine HCL 80mg in 0.9% Sodium Chloride Bag recalled	SCA Pharmaceuticals	Sterility	Nationwide

More recalls from SCA Pharmaceuticals

All 166

Reported	Class	Recall	Company	Reason	Where
3 Apr 2024Drug	CLASS II	fentaNYL 200 mcg/, Bupivacaine HCl recalled by SCA Pharmaceuticals	SCA Pharmaceuticals	Sterility	Nationwide
3 Apr 2024Drug	CLASS II	fentaNYL 2,500 mcg/ Injection (Concentration = 50 mcg/mL) 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	SUCcinylcholine Chloride 200 mg/ Injection recalled	SCA Pharmaceuticals	Sterility	Nationwide
3 Apr 2024Drug	CLASS II	PHENYLephrine HCl 500 mcg/ in 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	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