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Edge Pharma, LLC

Complete recall history across all FDA and CPSC categories — 62 total recalls

Edge Pharma, LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (62)

FDA drug safety enforcement actions by Edge Pharma, LLC. Showing most recent 50.

Date Product Reason Class
Dec 6, 2021 Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg... Lack of Assurance of Sterility Class II
Dec 6, 2021 Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container... CGMP Deviations Class II
Dec 6, 2021 Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), ... Lack of Assurance of Sterility Class II
Dec 6, 2021 CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphoteri... CGMP Deviations Class II
Dec 6, 2021 Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11... Lack of Assurance of Sterility Class II
Dec 6, 2021 Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Sing... Lack of Assurance of Sterility Class II
Dec 6, 2021 Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Mul... CGMP Deviations Class II
Dec 6, 2021 LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose C... CGMP Deviations Class II
Dec 6, 2021 Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injecti... CGMP Deviations Class II
Dec 6, 2021 PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL)... Lack of Assurance of Sterility Class II
Dec 6, 2021 Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile... Lack of Assurance of Sterility Class II
Dec 6, 2021 Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free,... Lack of Assurance of Sterility Class II
Dec 6, 2021 Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Prese... Lack of Assurance of Sterility Class II
Dec 6, 2021 Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial ... CGMP Deviations Class II
Dec 6, 2021 Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syrin... Lack of Assurance of Sterility Class II
Dec 6, 2021 Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic... Lack of Assurance of Sterility Class II
Dec 6, 2021 Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for I... Lack of Assurance of Sterility Class II
Dec 6, 2021 Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vi... Lack of Assurance of Sterility Class II
Dec 6, 2021 Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL pe... Lack of Assurance of Sterility Class II
Dec 6, 2021 Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.... Lack of Assurance of Sterility Class II
Dec 6, 2021 CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocor... CGMP Deviations Class II
Dec 6, 2021 Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg... Lack of Assurance of Sterility Class II
Dec 6, 2021 Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use S... Lack of Assurance of Sterility Class II
Dec 6, 2021 Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syrin... Lack of Assurance of Sterility Class II
Dec 6, 2021 Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic... Lack of Assurance of Sterility Class II
Dec 6, 2021 Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Contain... CGMP Deviations Class II
Dec 6, 2021 Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% /... CGMP Deviations Class II
Dec 6, 2021 Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preserva... Lack of Assurance of Sterility Class II
Dec 6, 2021 Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Singl... Lack of Assurance of Sterility Class II
Dec 6, 2021 Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% ... CGMP Deviations Class II
Dec 6, 2021 ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (... Lack of Assurance of Sterility Class II
Dec 6, 2021 Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single ... Lack of Assurance of Sterility Class II
Dec 6, 2021 Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenyl... CGMP Deviations Class II
Dec 6, 2021 Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmi... Lack of Assurance of Sterility Class II
Dec 6, 2021 Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syring... CGMP Deviations Class II
Dec 6, 2021 Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottl... CGMP Deviations Class II
Dec 6, 2021 Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0... Lack of Assurance of Sterility Class II
Dec 6, 2021 Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per... CGMP Deviations Class II
Dec 6, 2021 Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.... Lack of Assurance of Sterility Class II
Dec 6, 2021 Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Prese... Lack of Assurance of Sterility Class II
Dec 6, 2021 BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, ... CGMP Deviations Class II
Dec 6, 2021 Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / ... Lack of Assurance of Sterility Class II
Dec 6, 2021 Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL pe... CGMP Deviations Class II
Dec 6, 2021 Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5... Lack of Assurance of Sterility Class II
Dec 6, 2021 Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single D... CGMP Deviations Class II
Dec 6, 2021 Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Singl... CGMP Deviations Class II
Dec 6, 2021 LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%... CGMP Deviations Class II
Dec 6, 2021 Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe... Lack of Assurance of Sterility Class II
Dec 6, 2021 Dexamethasone sodium phosphate, sterile otic solution for injection Preservat... Lack of Assurance of Sterility Class II
Dec 6, 2021 Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL pe... CGMP Deviations Class II

View all 62 drug recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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