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Apollo Care, LLC

FDA Regulatory Profile

Apollo Care, LLC has 34 FDA recalls, 4 inspections, 0 510(k) clearances and 2 compliance actions on record.

Latest recall
D-0749-2026 · Class II · Jul 29, 2026
Latest inspection
Mar 27, 2025 · OAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls34Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections4Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions2Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
D-0749-2026Class IISEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection…Jul 29, 2026
D-0747-2026Class IISEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection…Jul 29, 2026
D-0752-2026Class IISEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection…Jul 29, 2026
D-0750-2026Class IISEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection…Jul 29, 2026
D-0748-2026Class IISEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection…Jul 29, 2026
D-0753-2026Class IISEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For…Jul 29, 2026
D-0754-2026Class IISEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For…Jul 29, 2026
D-0757-2026Class IISEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For…Jul 29, 2026
D-0755-2026Class IISEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For…Jul 29, 2026
D-0756-2026Class IISEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For…Jul 29, 2026
D-0751-2026Class IISEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only…Jul 29, 2026
D-0409-2025Class IIFentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride…Apr 15, 2025
D-0633-2023Class IISuccinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), Single-Use Syringe, Rx only, Apollo Care…May 2, 2023
D-0641-2023Class IIVANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801…May 2, 2023
D-0642-2023Class IIVANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Apollo Care, LLC, 3801…May 2, 2023
D-0636-2023Class IIVANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801…May 2, 2023
D-0644-2023Class IINorepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo Care, LLC, 3801 Mojave…May 2, 2023
D-0646-2023Class IIFentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride…May 2, 2023
D-0643-2023Class IIVANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801…May 2, 2023
D-0645-2023Class IIVANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801…May 2, 2023

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 27, 2025Columbia, MODrugsOfficial Action Indicated (OAI)3013927023
Apr 5, 2023Columbia, MODrugsOfficial Action Indicated (OAI)3013927023
Sep 8, 2021Columbia, MODrugsOfficial Action Indicated (OAI)3013927023
Mar 13, 2018Columbia, MODrugsOfficial Action Indicated (OAI)3013927023

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 3013927023Columbia, MO4Mar 27, 2025

FDA data resources

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