Edge Pharma recalls

Edge Pharma has 62 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 2 Feb 2022. The most frequent reason is sterility.

Total recalls62since 2020
Last 12 months0reported
Class I00% of total
Ongoing0latest 2 Feb 2022

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 60 97%Class III 2 3%

By year

All edge pharma recalls, newest first

62 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIPhenylephrine HCl, Sterile Solution for Injection, (PF) recalledEdge PharmaSterilityNationwide
DrugCLASS IITetracaine HCl Nasal Solution recalled by Edge PharmaEdge PharmaManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIMethotrexate, USP, Sterile Solution for Injection (PF) recalledEdge PharmaSterilityNationwide
DrugCLASS IICSF Otic Insufflation Capsule recalled by Edge PharmaEdge PharmaManufacturing (CGMP) DeviationsNationwide
DrugCLASS IICeftazidime, Sterile Ophthalmic Solution for Injection recalledEdge PharmaSterilityNationwide
DrugCLASS IIVancomycin HCl in 0.9 % Sodium Chloride Injection recalledEdge PharmaSterilityNationwide
DrugCLASS IILidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1% recalledEdge PharmaManufacturing (CGMP) DeviationsNationwide
DrugCLASS IILT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm recalledEdge PharmaManufacturing (CGMP) DeviationsNationwide
DrugCLASS IITrypan Blue 0.03% per syringe recalled by Edge PharmaEdge PharmaManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIPHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg recalledEdge PharmaSterilityNationwide
DrugCLASS IILidocaine HCL / Bupivacaine HCL (contains Hyaluronidase/mL) recalledEdge PharmaSterilityNationwide
DrugCLASS IIVancomycin HCl, Sterile Ophthalmic Solution for Injection recalledEdge PharmaSterilityNationwide
DrugCLASS IIMethacholine Challenge 5-Syringe Test Kit recalled by Edge PharmaEdge PharmaSterilityNationwide
DrugCLASS IICantharidin Gel-Forming Suspension, 0.7% per vial recalledEdge PharmaManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIPhenylephrine HCl 0.5 mg/, (0.1 mg/mL) per syringe recalledEdge PharmaSterilityNationwide
DrugCLASS IIPhenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac recalledEdge PharmaSterilityNationwide
DrugCLASS IIMitomycin-C, 40mg/ (1mg/mL) per syringe recalled by Edge PharmaEdge PharmaSterilityNationwide
DrugCLASS IIPhenol, Sterile Solution for Injection (PF), 6% per vial recalledEdge PharmaSterilityNationwide
DrugCLASS IIPhenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution recalledEdge PharmaSterilityNationwide
DrugCLASS IIMitomycin-C, Sterile Ophthalmic Solution, Preservative Free recalledEdge PharmaSterilityNationwide
DrugCLASS IICsf-hc Otic Insufflation Capsule, Sulfacetamide recalled by Edge PharmaEdge PharmaManufacturing (CGMP) DeviationsNationwide
DrugCLASS IICefuroxime, Sterile Ophthalmic Solution for Injection recalledEdge PharmaSterilityNationwide
DrugCLASS IINeostigmine methylsulfate, 5 mg/ (1 mg/mL) per syringe recalledEdge PharmaSterilityNationwide
DrugCLASS IILidocaine HCl Sterile Buffered Solution for Injection recalledEdge PharmaSterilityNationwide
DrugCLASS IIPhenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac recalledEdge PharmaSterilityNationwide
DrugCLASS IIDexamethasone sodium phosphate recalled by Edge PharmaEdge PharmaManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIProfound Dental Gel, Lidocaine HCl/Prilocaine recalled by Edge PharmaEdge PharmaManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIEpinephrine/Lidocaine HCl Sterile Ophthalmic Solution recalledEdge PharmaSterilityNationwide
DrugCLASS IIVancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg recalledEdge PharmaSterilityNationwide
DrugCLASS IIProfound Dental Gel, Lidocaine HCl/Prilocaine recalled by Edge PharmaEdge PharmaManufacturing (CGMP) DeviationsNationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.