CLASS II Drug recall · Reported 2 Aug 2017 · FDA Enforcement Report

PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, Preservative Free recalled

SCA Pharmaceuticals is recalling PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, Preservative Free, distributed nationwide in the US. The recall was initiated on 14 Jul 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: 20170503@26 BUD: 8/1/2017; 20170510@48 BUD: 8/8/2017

Quantity recalledN/A

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-1025-2017
FDA event ID: 77770
Recalling firm: SCA Pharmaceuticals, Little Rock, AR
Classification: Class II
Status: Terminated
Recall initiated: 14 Jul 2017
FDA classified: 26 Jul 2017
Reported: 2 Aug 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Cold & Cough Medicine

Timeline

14 Jul 2017	Recall initiated by company
26 Jul 2017	Classified by FDA	+12 days
2 Aug 2017	Published in enforcement report	+7 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; product has the potential to leak.

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 10 mg in 0.9% Sodium Chloride 250 mL Bag, Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0811-40

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility; product has the potential to leak.

Which lots are affected?

Lots: 20170503@26 BUD: 8/1/2017; 20170510@48 BUD: 8/8/2017

Where was it sold?

Nationwide

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

29 other products · FDA event 77770

This product is part of a recall event; the main page for the event is PHENYLephrine 40 mg in 0.9% Sodium Chloride recalled.

Reported	Class	Recall	Company	Reason	Where
2 Aug 2017	CLASS II	PHENYLephrine 40 mg in 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	PHENYLephrine HCl 60 mg in 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	PHENYLephrine 20 mg in 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	PHENYLephrine 200 mg in 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	fentaNYL 2 mcg/mL+Bupivacaine 0.0625% PF in 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	fentaNYL (as citrate) 5 mcg/mL In 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	BUPIVacaine HCl 0.125% In 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	fentaNYL 2 mcg/mL + BUPIvacaine 0.125% PF in 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	fentaNYL 10 mcg/mL PF in NS Fill in syringe recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	PHENYLephrine 50 mg in 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	fentaNYL 2 mcg/mL + BUPIvacaine 0.1% PF in 0.9% NS recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	Hydromorphone 0.5 mg/mL in 0.9% Sodium Chloride Fill in BD syringe recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	ePHEDrine Sulfate 5 mg/mL in NS Fill in Syringe (25 mg) recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	fentaNYL as citrate 5 mcg/mL in 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	PHENYLephrine 10 mg in 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	BUPIVacaine HCl 0.2% IN 0.9% Sodium Chloride Bag recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	NORepinephrine 4 mg in 0.9% Sodium Chloride from Stock recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	BUPIVacaine HCl 0.1% PF (From 0.75%) recalled by SCA Pharmaceuticals	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	Potassium Chloride 20 meq Added to Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	Potassium Chloride 40 meq Added to Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	fentaNYL 10 mcg/mL PF in Sodium Chloride (Total Dose=2500 mcg) recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	NORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	NORepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride from Stock recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	PHENYLephrine HCl 25 mg in 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	PHENYLephrine 100 mg in 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	fentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
2 Aug 2017	CLASS II	EPINEPHrine HCl 4 mg in 0.9% Sodium Chloride 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