CLASS II Drug recall · Reported 3 Apr 2024 · FDA Enforcement Report

HYDROmorphone HCl 20 mg/ in 0.9% Sodium Chloride Injection recalled

SCA Pharmaceuticals is recalling HYDROmorphone HCl 20 mg/ in 0.9% Sodium Chloride Injection Grey CADD Cassette (20 mg/, CII, distributed nationwide in the US. The recall was initiated on 9 Nov 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 1223049529, Exp 01/03/24
Quantity recalled256 cassettes

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-0404-2024
FDA event ID
93456
Recalling firm
SCA Pharmaceuticals, Windsor, CT
Classification
Class II
Status
Terminated
Recall initiated
9 Nov 2023
FDA classified
22 Mar 2024
Reported
3 Apr 2024
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility
Drug class
Pain Medication

Timeline

9 Nov 2023Recall initiated by company
22 Mar 2024Classified by FDA+134 days
3 Apr 2024Published in enforcement report+12 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

HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-63, Bar Code 70004030063

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?

Lot #: 1223049529, Exp 01/03/24

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

31 other products · FDA event 93456

This product is part of a recall event; the main page for the event is PHENYLephrine HCl 5000 mcg recalled by SCA Pharmaceuticals.

ReportedClassRecallCompanyReasonWhere
CLASS IIPHENYLephrine HCl 5000 mcg recalled by SCA PharmaceuticalsSCA PharmaceuticalsSterilityNationwide
CLASS IIlabetalol HCl 20 mg/ Injection, (Concentration=5 mg/mL) fill Syringe recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIHYDROmorphone HCl 30 mg/ in 0.9% Sodium Chloride Injection recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIPHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIfentaNYL 100 mcg/, Bupivacaine HCl recalled by SCA PharmaceuticalsSCA PharmaceuticalsSterilityNationwide
CLASS IIfentaNYL 1,250 mcg/ Injection recalled by SCA PharmaceuticalsSCA PharmaceuticalsSterilityNationwide
CLASS IIHYDROmorphone HCl 10 mg/ in 0.9% Sodium Chloride Injection recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIPHENYLephrine HCl 400 mcg/ in 0.9% Sodium Chloride recalledSCA PharmaceuticalsSterilityNationwide
CLASS IISUCcinylcholine Chloride 100 mg/ Injection recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIfentaNYL 2,500 mcg/ in 0.9% Sodium Chloride Injection recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIfentaNYL 2,500 mcg/ in 0.9 % Sodium Chloride Injection recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIneostigmine methylsulfate 5 mg/ Injection recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIHYDROmorphone HCl 6 mg/ in 0.9% Sodium Chloride recalledSCA PharmaceuticalsSterilityNationwide
CLASS IISodium Citrate 4%, Anticoagulation Solution Injection recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIfentaNYL 500 mcg/, Bupivacaine HCl recalled by SCA PharmaceuticalsSCA PharmaceuticalsSterilityNationwide
CLASS IIPHENYLephrine HCl 800 mcg/ in 0.9% Sodium Chloride recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIPHENYLephrine HCl 800 mcg/ in 0.9% Sodium Chloride recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIHYDROmorphone HCl 25 mg/ in 0.9% Sodium Chloride Injection recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIMidazolam HCl 100 mg/ in 0.9% Sodium Chloride Injection recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIDiltiazem HCl 125 mg in 0.9% Sodium Chloride Injection recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIfentaNYL 200 mcg/, Bupivacaine HCl recalled by SCA PharmaceuticalsSCA PharmaceuticalsSterilityNationwide
CLASS IIPHENYLephrine HCl 1000 mcg recalled by SCA PharmaceuticalsSCA PharmaceuticalsSterilityNationwide
CLASS IIfentaNYL 500 mcg/, Bupivacaine HCl recalled by SCA PharmaceuticalsSCA PharmaceuticalsSterilityNationwide
CLASS IIHYDROmorphone HCl 6 mg/ in 0.9% Sodium Chloride Injection recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIVancomycin added to 0.9% Sodium Chloride Injection recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIHYDROmorphone HCl 30 mg/ in 0.9% Sodium Chloride Injection recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIPHENYLephrine HCl 500 mcg/ in 0.9% Sodium Chloride recalledSCA PharmaceuticalsSterilityNationwide
CLASS IISUCcinylcholine Chloride 200 mg/ Injection recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIPHENYLephrine HCl 500 mcg/ in 0.9% Sodium Chloride recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIfentaNYL 2,500 mcg/ Injection (Concentration = 50 mcg/mL) recalledSCA PharmaceuticalsSterilityNationwide
CLASS IIfentaNYL 200 mcg/, Bupivacaine HCl recalled by SCA PharmaceuticalsSCA 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 Hydromorphone recalls

All 155
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIIHYDROmorphone Hydrochloride 50mg/ (1mg/mL) recalled by OurPharmaOurPharmaPotency & AssayNationwide
DrugCLASS IIHYDROmorphone HCl 30 mg/ in 0.9% Sodium Chloride Injection recalledSCA PharmaceuticalsSterilityNationwide
DrugCLASS IIHYDROmorphone HCl 6 mg/ in 0.9% Sodium Chloride Injection recalledSCA PharmaceuticalsSterilityNationwide
DrugCLASS IIHYDROmorphone HCl 25 mg/ in 0.9% Sodium Chloride Injection recalledSCA PharmaceuticalsSterilityNationwide
DrugCLASS IIHYDROmorphone HCl 6 mg/ in 0.9% Sodium Chloride recalledSCA PharmaceuticalsSterilityNationwide