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

BUPIVacaine HCl 0.125% In 0.9% Sodium Chloride recalled

SCA Pharmaceuticals is recalling BUPIVacaine HCl 0.125% In 0.9% Sodium Chloride, Preservative Free (Total Dose Bupivacaine, 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 codesLot: 20170502@32 BUD: 7/31/2017

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-1006-2017
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: Injectable & IV Drugs

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

BUPIVacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag, Preservative Free (Total Dose Bupivacaine 312.5 mg per 250 mL), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0062-40

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?

Lot: 20170502@32 BUD: 7/31/2017

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

All 54

Reported	Class	Recall	Company	Reason	Where
22 Apr 2026Drug	CLASS II	Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection recalledBupivacaine Hydrochloride	Huons	Sterility	Nationwide
9 Jul 2025Drug	CLASS II	BUPIVAcaine HCL Sterile injection recalled by Tailstorm Health	Tailstorm Health	Sterility	Nationwide
25 Jan 2023Drug	CLASS II	Sensorcaine (Bupivacaine HCl and Epinephrine Injection recalledSensorcaine	Fresenius Kabi USA	Potency & Assay	Nationwide
25 Jan 2023Drug	CLASS II	Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection recalledSensorcaine	Fresenius Kabi USA	Potency & Assay	Nationwide
25 Jan 2023Drug	CLASS II	Sensorcaine (Bupivacaine HCl and Epinephrine Injection recalledSensorcaine	Fresenius Kabi USA	Potency & Assay	Nationwide