Manufacturer

Edge Pharma, LLC

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

What the numbers show

Total: 62
Critical: 0
Severe: 27
Most recent: 2022-02-02

Of the 62 recalls from Edge Pharma, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 27 (44%) are Severe.

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.

51–62 of 62

ModerateFDA (Drugs)·D-0432-2022·2022-02-02
CSF-HC Otic Powder Drug Recalled for Manufacturing Deviations
Edge Pharma, LLC is recalling CSF-HC Otic Insufflation Capsule nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 440 cartons of this antibiotic and steroid combination powder.
Product
CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B Otic Powder, 50mg/ 30mg/ 25mg/ 5mg, 5 count bottle, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1634-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0430-2022·2022-02-02
Cantharidin PLUS topical suspension recalled for manufacturing deviations
Edge Pharma, LLC is recalling 2,204 vials of Cantharidin PLUS, a topical gel-forming suspension used to treat skin conditions. The recall is due to manufacturing quality control deviations discovered during production.
Product
Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL per vial, Multiple Dose Vials for Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0970-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0439-2022·2022-02-02
Drug Recall: Profound Dental Gel CGMP Deviations
Edge Pharma is voluntarily recalling 353 jars of Profound Dental Gel nationwide due to Current Good Manufacturing Practice (CGMP) deviations identified during the manufacturing process.
Product
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry Marshmallow, 30 grams per jar, Multiple Dose Container For Topical Oral Use,Edge Pharma LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0790-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0409-2022·2022-02-02
Mitomycin-C Ophthalmic Solution Recall Due to Sterility Assurance
Edge Pharma is recalling Mitomycin-C sterile ophthalmic solution syringes because the manufacturer lacks assurance of sterility. The recall affects 154 syringes distributed nationwide.
Product
Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 mg/mL), 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1011-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0436-2022·2022-02-02
LT Topical Cream Recalled for Manufacturing Practice Deviations
Edge Pharma, LLC is recalling 74 jars of LT Topical Cream (Lidocaine/Tetracaine) nationwide due to deviations from Current Good Manufacturing Practice (CGMP). The firm initiated the voluntary recall on December 6, 2021.
Product
LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for Topical Use, Edge Pharma, LLC, 856 Hercules, VT, Colchester, VT 05446, NDC 05446-1647-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0442-2022·2022-02-02
Profound-PE Dental Gel Recalled for Manufacturing Deviations
Edge Pharma, LLC is recalling Profound-PE Dental Gel nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 175 jars of the topical oral anesthetic gel.
Product
Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / 10% / 4% / 2%, Spear-Peppermint, Multiple Dose Container for Topical Oral Use, 30 grams per jar, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0408-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0335-2021·2021-04-28
Edge Pharma Recalls Betadine Ophthalmic Syringes Due to Sterility Concerns
Edge Pharma is recalling 5,850 syringes of Betadine ophthalmic solution because a defective container may compromise sterility. The product is distributed nationwide.
Product
Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION, PRESERVATIVE FREE, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0306-2021·2021-03-24
Edge Pharma Recalls Methacholine Challenge Test Kits Due to Storage Labeling Error
Edge Pharma is recalling Methacholine Challenge 5-Syringe Test Kits because they were labeled with incorrect room temperature storage conditions instead of the required refrigerated conditions.
Product
Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Dolchester, VT 06448 NDC # 05446-1600-05
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0307-2021·2021-03-24
Edge Pharma Recalls Epinephrine/Lidocaine Ophthalmic Solution Due to Labeling Errors
Edge Pharma, LLC is recalling 60 syringes of Epinephrine/Lidocaine HCl sterile ophthalmic solution for injection due to incorrect or missing lot and expiration dates.
Product
Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.75%, Rx only, Edge Pharma LLC 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0238-2021·2021-01-27
Edge Pharma Recalls Ceftazidime Sterile Ophthalmic Solution Due to Sterility Concerns
Edge Pharma, LLC is recalling 48 syringes of Ceftazidime Sterile Ophthalmic Solution because the media used for sterility testing was expired, compromising the assurance of sterility.
Product
Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe. KEEP FROZEN UNTIL USE AND PROTECT FROM LIGHT SINGLE USE SYRINGE FOR INTRAOCULAR INJECTION Edge Pharma, LLC is an FDA-registered 503B outsourcing facility. This…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0226-2021·2021-01-20
Edge Pharma Recalls Methotrexate Syringes Due to Sterility Testing Concerns
Edge Pharma, LLC is recalling 71 syringes of Methotrexate USP Sterile Solution for Injection because the media used for post-compounding sterility testing was expired.
Product
Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRINGE FOR IM INJECTION, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178, Barcode 0544650505
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1562-2020·2020-09-16
Edge Pharma Recalls Vancomycin IV Bags Due to Labeling Error
Edge Pharma, LLC is recalling Vancomycin HCL 1.5 mg IV bags distributed in Wisconsin due to a label error regarding the declared strength.
Product
Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 NDC 05446-1458-01
Category
Drug
Distribution
1 state