thejoe SCA Pharmaceuticals

SCA Pharmaceuticals: 107 FDA recall reports

Every drug recall the FDA has published for SCA Pharmaceuticals. The fault, and how the agency graded it.

107Reports

11Class I

0Ongoing

2023-08-02Most recent

11 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	92
Class I	11
Class III	4

By year reported

Year	Reports
2015	3
2017	57
2018	2
2020	7
2021	32
2022	3
2023	3

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (

D-0945-2023 · Class II · reported 2023-08-02 · Terminated

Why it was recalled: cGMP deviations: due to shipment of rejected units.
Product: FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40
Where it went: KY and NJ
How much: 183 bags

Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, W

D-0555-2023 · Class III · reported 2023-05-03 · Terminated

Why it was recalled: Subpotent Drug: Out of specification results for low potency was obtained.
Product: Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC# 70004-085-44
Where it went: Nationwide in the USA
How much: 73,312 containers

Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free,

D-0363-2023 · Class III · reported 2023-03-08 · Terminated

Why it was recalled: Subpotent Drug
Product: Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor CT 06095, NDC# 70004-0200-16.
Where it went: Nationwide in the US.
How much: 2125 syringes

Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC

D-0831-2022 · Class II · reported 2022-05-11 · Terminated

Why it was recalled: CGMP Deviations
Product: Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0924-44
Where it went: Product was distributed nationwide within the United States
How much: 30 bags

Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 700

D-0829-2022 · Class II · reported 2022-05-11 · Terminated

Why it was recalled: CGMP Deviations
Product: Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-078-40
Where it went: Product was distributed nationwide within the United States
How much: 120 bags

Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Wind

D-0830-2022 · Class II · reported 2022-05-11 · Terminated

Why it was recalled: CGMP Deviations
Product: Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0231-32
Where it went: Product was distributed nationwide within the United States
How much: 424 bags

HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50 mL Single Dose Syringe, SCA Ph

D-0215-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product: HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004030022
Where it went: Product was distributed to hospitals nationwide.
How much: 428 syringes

ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe, Rx Only, SCA Pharma

D-0189-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product: ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004060412
Where it went: Product was distributed to hospitals nationwide.
How much: 7,257 syringes

PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Ph

D-0216-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product: PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081022
Where it went: Product was distributed to hospitals nationwide.
How much: 3152 syringes

ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceutical

D-0213-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product: ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals 8521 Knoedl Ct., Little Rock, AR, 72205, barcode 70004060409
Where it went: Product was distributed to hospitals nationwide.
How much: 9416 syringes

fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only,

D-0191-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product: fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004026422
Where it went: Product was distributed to hospitals nationwide.
How much: 1,774 syringes

Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SCA Pharmaceuti

D-0207-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product: Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090025
Where it went: Product was distributed to hospitals nationwide.
How much: 5,990 syringes

morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx Only, 30 mL Single Dose Syringe

D-0202-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product: morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010316
Where it went: Product was distributed to hospitals nationwide.
How much: 50 syringes

ePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single Dose Syringe, Rx Only, SCA Pharma

D-0188-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product: ePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004060509
Where it went: Product was distributed to hospitals nationwide.
How much: 1,879 syringes

Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd.

D-0190-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product: Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004062012
Where it went: Product was distributed to hospitals nationwide.
How much: 952 syringes

Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd.,

D-0194-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product: Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004063809
Where it went: Product was distributed to hospitals nationwide.
How much: 1,614 syringes

fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals,

D-0214-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product: fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006
Where it went: Product was distributed to hospitals nationwide.
How much: 6710 syringes

Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 7

D-0186-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product: Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004004006
Where it went: Product was distributed to hospitals nationwide.
How much: 1,930 syringes

Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pharma, Inc., 755 Rainbow Rd., Winds

D-0199-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product: Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pharma, Inc., 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072012
Where it went: Product was distributed to hospitals nationwide.
How much: 1,880 syringes

neostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Ra

D-0203-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product: neostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004075009
Where it went: Product was distributed to hospitals nationwide.
How much: 390 syringes

SUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd.,

D-0212-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product: SUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., WIndsor, CT, 06095, barcode 70004090809
Where it went: Product was distributed to hospitals nationwide.
How much: 5067 syringes

Lidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor

D-0200-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product: Lidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072309
Where it went: Product was distributed to hospitals nationwide.
How much: 7,275 syringes

Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30 mL Single Dose Syringe, SCA Ph

D-0209-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product: Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010016
Where it went: Product was distributed to hospitals nationwide.
How much: 116 syringes

Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SC

D-0197-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product: Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043012
Where it went: Product was distributed to hospitals nationwide.
How much: 11,075 syringes

fentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd.,

D-0193-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product: fentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004020016
Where it went: Product was distributed to hospitals nationwide.
How much: 2,834 syringes

HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syr

D-0196-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product: HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (barcode 70004030316) and b) 30 mL Single Dose Syringe (barcode 70004030321), Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095
Where it went: Product was distributed to hospitals nationwide.
How much: 1,056 syringes

fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only

D-0192-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product: fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals,755 Rainbow Rd., Windsor, CT, 06095, barcode 70004023122
Where it went: Product was distributed to hospitals nationwide.
How much: 996 syringes

Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 ml Single Dose Syringe, SCA Pharma

D-0201-2021 · Class III · reported 2021-01-13 · Terminated

Why it was recalled: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product: 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 went: Product was distributed to hospitals nationwide.
How much: 751 syringes

PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5 mL Single Dose Syringe, SCA Ph

D-0210-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product: PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081011
Where it went: Product was distributed to hospitals nationwide.
How much: 14,580 syringes

labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4 mL Single Dose Syringe, SCA Phar

D-0198-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product: labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004070028
Where it went: Product was distributed to hospitals nationwide.
How much: 9,057 syringes

Showing the 30 most recent of 107. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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