The Recall Desk

Manufacturer

Edge Pharma, LLC

56 recalls in our database name Edge Pharma, LLC as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–56 of 56

  • ModerateFDA (Drugs)·D-0441-2022·2022-02-02

    Profound-PE Dental Gel Recalled Due to Manufacturing Deviations

    Edge Pharma, LLC is recalling Profound-PE Dental Gel nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 418 jars of the topical oral anesthetic product distributed across multiple lot codes.

    Product
    Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% / 4% / 2% Raspberry-Marshmallow, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-1018-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0438-2022·2022-02-02

    Lidocaine HCl / Oxymetazoline HCl Nasal Solution Recalled for CGMP Deviations

    Edge Pharma, LLC is recalling Lidocaine HCl / Oxymetazoline HCl Nasal Solution (4% / 0.05%, 240mL) nationwide due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1256-01, packaged in bottles. no label
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0443-2022·2022-02-02

    Phenol Topical Solution recalled for CGMP manufacturing deviations

    Edge Pharma, LLC is recalling 1,861 vials of Phenol, Topical Solution (PF) 89%, 3 mL per vial, distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-1211-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0444-2022·2022-02-02

    Lidocaine HCl/Phenylephrine HCl Nasal Solution Recalled for CGMP Deviations

    Edge Pharma, LLC is recalling Lidocaine HCl/Phenylephrine HCl Nasal Solution (4%/1%) nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall involves 231 bottles.

    Product
    Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multiple Dose Container, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1045-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0437-2022·2022-02-02

    LET Topical Gel drug recall for CGMP deviations

    Edge Pharma is recalling 26,917 syringes of LET Topical Gel nationwide due to current Good Manufacturing Practice (CGMP) deviations. The recall was initiated voluntarily in December 2021.

    Product
    LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per syringe, Single Dose Syringe for Topical Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT, NDC 05446-0607-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0431-2022·2022-02-02

    FDA Recalls CSF Otic Insufflation Capsule for CGMP Deviations

    Edge Pharma, LLC is recalling 1055 bottles of CSF Otic Insufflation Capsule containing Sulfacetamide Sodium, Ciprofloxacin, and Amphotericin B nationwide due to CGMP manufacturing deviations.

    Product
    CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic Powder, 50mg / 30mg / 5mg, 5 count bottle, For Otic Use with Insufflator, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1633-05
    Category
    Drug
    Distribution
    Distributed nationwide