CLASS III Drug recall · Reported 13 Jan 2021 · FDA Enforcement Report

Morphine Sulfate 3 mg/ in 0.9% Sodium Chloride (1mg/mL) CII recalled

SCA Pharmaceuticals is recalling Morphine Sulfate 3 mg/ in 0.9% Sodium Chloride (1mg/mL) CII, distributed nationwide in the US. The recall was initiated on 17 Dec 2020 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot # 1220023452, BUD 2/7/2021
Quantity recalled751 syringes

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-0201-2021
FDA event ID
86990
Recalling firm
SCA Pharmaceuticals, Windsor, CT
Classification
Class III
Status
Terminated
Recall initiated
17 Dec 2020
FDA classified
7 Jan 2021
Reported
13 Jan 2021
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility
Drug class
Pain Medication

Timeline

17 Dec 2020Recall initiated by company
7 Jan 2021Classified by FDA+21 days
13 Jan 2021Published in enforcement report+6 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; potential for a defective syringe cap, resulting in a non-integral unit

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

Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 ml Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010025

Where it was distributed

Product was distributed to hospitals nationwide.

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

Which lots are affected?

Lot # 1220023452, BUD 2/7/2021

Where was it sold?

Product was distributed to hospitals 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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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

31 other products · FDA event 86990

This product is part of a recall event; the main page for the event is HYDROmorphone HCl 10mg/ in 0.9% Sodium Chloride Injection, CII recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIHYDROmorphone HCl 10mg/ in 0.9% Sodium Chloride Injection, CII recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIePHEDrine Sulfate 50 mg/ in 0.9% Sodium Chloride Injection recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIPHENYLephrine HCl 5000 mg/ in Sodium Chloride 0.9% (100 mcg/mL) recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIePHEDrine 25 mg/ in 0.9% Sodium Chloride Injection recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIfentaNYL 100 mcg/ Ropivacaine HCl recalled by SCA PharmaceuticalsSCA PharmaceuticalsSterilityNationwide
CLASS IISodium Citrate 4% Anticoagulation Solution (40mg/mL) recalledSCA PharmaceuticalsSterilityNationwide
CLASS IImorphine sulfate 150 mg/ in 0.9% Sodium Chloride Injection recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIePHEDrine Sulfate, 50 mg/ in 0.9% Sodium Chloride Injection recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIEsmolol HCl 100 mg/ (10mg/ mL) Single Dose Syringe recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIGlycopyrrolate 1 mg/ (0.2mg/mL) Single Dose Syringe recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIfentaNYL 100 mcg/ Injection recalled by SCA PharmaceuticalsSCA PharmaceuticalsSterilityNationwide
CLASS IIAtropine Sulfate Injection, 0.8 mg/ (0.4 mg/mL) Single Dose Syringe recalledSCA PharmaceuticalsSterilityNationwide
CLASS IILidocaine HCl 1% (10mg/ml) recalled by SCA PharmaceuticalsSCA PharmaceuticalsSterilityNationwide
CLASS IIneostigmine methylsulfate 5 mg/, (1mg/ml) recalledSCA PharmaceuticalsSterilityNationwide
CLASS IISUCcinylcholine Chloride 100 mg recalled by SCA PharmaceuticalsSCA PharmaceuticalsSterilityNationwide
CLASS IILidocaine HCl 2%, 20 mg/mL recalled by SCA PharmaceuticalsSCA PharmaceuticalsSterilityNationwide
CLASS IIMorphine Sulfate 30 mg/ in 0.9% Sodium Chloride (1mg/ml), CII recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIKetamine 100 mg/ in 0.9% Sodium Chloride Injection (10 mg/mL), CII recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIfentaNYL 1500 mcg/ (50 mcg/mL) Single Dose Syringe recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIHYDROmorphone HCl 30 mg/ in 0.9% Sodium Chloride Injection recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIfentaNYL 100 mcg/ Bupivacaine HCl recalled by SCA PharmaceuticalsSCA PharmaceuticalsSterilityNationwide
CLASS IIPHENYLephrine HCl 500 mcg/ in 0.9% Sodium Chloride (100 mcg/mL) recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIlabetalol HCl 20 mg/, Injection for Intravenous Use (5mg/mL) recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIHYDROmorphone HCl 6 mg/ in 0.9% Sodium Chloride Injection recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIRocuronium Br 100 mg/ (10 mg/mL) recalled by SCA PharmaceuticalsSCA PharmaceuticalsSterilityNationwide
CLASS IIBuffered Lidocaine HCl, 1% (10mg/mL) recalled by SCA PharmaceuticalsSCA PharmaceuticalsSterilityNationwide
CLASS IISUCccinylcholine Chloride 200 mg/, (20 mg/mL) recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIRocuronium Br 50 mg/ (10 mg/mL) recalled by SCA PharmaceuticalsSCA PharmaceuticalsSterilityNationwide
CLASS IIPHENYLephrine HCl 800 mcg/ in 0.9% Sodium Chloride (80 mcg/mL) recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIPHENYLephrine HCl 1000 mcg/ in 0.9% Sodium Chloride, (100 mcg/mL) recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIKetamine 50 mg/ in 0.9% Sodium Chloride Injection (10 mg/mL), CII recalledSCA PharmaceuticalsSterilityNationwide

More recalls from SCA Pharmaceuticals

All 166
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIfentaNYL 200 mcg/, Bupivacaine HCl recalled by SCA PharmaceuticalsSCA PharmaceuticalsSterilityNationwide
DrugCLASS IIfentaNYL 2,500 mcg/ Injection (Concentration = 50 mcg/mL) recalledSCA PharmaceuticalsSterilityNationwide
DrugCLASS IIPHENYLephrine HCl 500 mcg/ in 0.9% Sodium Chloride recalledSCA PharmaceuticalsSterilityNationwide
DrugCLASS IISUCcinylcholine Chloride 200 mg/ Injection recalledSCA PharmaceuticalsSterilityNationwide
DrugCLASS IIPHENYLephrine HCl 500 mcg/ in 0.9% Sodium Chloride recalledSCA PharmaceuticalsSterilityNationwide

Other Morphine recalls

All 147
ReportedClassRecallCompanyReasonWhere
DrugCLASS IMorphine Sulfate Injection recalled by Fresenius Kabi USAMorphine SulfateFresenius Kabi USAPackaging DefectsNationwide
DrugCLASS IIIMorphine Sulfate Oral Solution 100 mg / (20 mg* / mL) recalledMorphine SulfateWinder LaboratoriesPackaging DefectsNationwide
DrugCLASS IIMorphine Sulfate Extended-Release Tablets, 100 mg recalledMorphine SulfateSUN Pharmaceutical IndustriesPotency & AssayNationwide
DrugCLASS IIMorphine Sulfate Extended-Release Tablets 30 mg recalledDr. Reddy's LaboratoriesPotency & AssayNationwide
DrugCLASS IIInfumorph (Preservative-free Morphine Sulfate Sterile recalledInfumorph 200Hikma Pharmaceuticals USAOtherNationwide