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SCA Pharmaceuticals

FDA Regulatory Profile

SCA Pharmaceuticals has 166 FDA recalls (12 Class I), 7 inspections, 0 510(k) clearances and 2 compliance actions on record.

Latest recall
D-0402-2024 · Class II · Nov 9, 2023
Latest inspection
Oct 30, 2025 · OAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls166 (12 Class I)Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections7Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions2Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
D-0402-2024Class IIfentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose…Nov 9, 2023
D-0424-2024Class IISUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx…Nov 9, 2023
D-0397-2024Class IIfentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL…Nov 9, 2023
D-0419-2024Class IIPHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag…Nov 9, 2023
D-0422-2024Class IISodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill…Nov 9, 2023
D-0404-2024Class IIHYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20…Nov 9, 2023
D-0407-2024Class IIHYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL…Nov 9, 2023
D-0408-2024Class IIHYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL…Nov 9, 2023
D-0423-2024Class IISUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12 mL Syringe…Nov 9, 2023
D-0401-2024Class IIfentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL…Nov 9, 2023
D-0405-2024Class IIHYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL…Nov 9, 2023
D-0411-2024Class IIlabetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma…Nov 9, 2023
D-0421-2024Class IIPHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL…Nov 9, 2023
D-0414-2024Class IIPHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10…Nov 9, 2023
D-0416-2024Class IIPHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL…Nov 9, 2023
D-0410-2024Class IIHYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill…Nov 9, 2023
D-0396-2024Class IIfentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx…Nov 9, 2023
D-0417-2024Class IIPHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50…Nov 9, 2023
D-0400-2024Class IIfentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL…Nov 9, 2023
D-0403-2024Class IIfentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single…Nov 9, 2023

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 30, 2025Little Rock, ARDrugsOfficial Action Indicated (OAI)3010683157
Dec 20, 2024Windsor, CTDrugsVoluntary Action Indicated (VAI)3013736415
Oct 20, 2023Windsor, CTDrugsOfficial Action Indicated (OAI)3013736415
May 17, 2023Little Rock, ARDrugsVoluntary Action Indicated (VAI)3010683157
Nov 7, 2019Little Rock, ARDrugsVoluntary Action Indicated (VAI)3010683157
Sep 29, 2017Little Rock, ARDrugsOfficial Action Indicated (OAI)3010683157
Apr 2, 2014Little Rock, ARDrugsOfficial Action Indicated (OAI)3010683157

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3010683157Little Rock, AR5Oct 30, 2025
FEI 3013736415Windsor, CT2Dec 20, 2024

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.