Edge Pharma, LLC

FDA recalling firm · 7 enforcement events · 62 product records · 2020–2021 · VT

Edge Pharma, LLC has 7 FDA enforcement events on this register (62 product records) between 2020 and 2021: 7 drug; the busiest year was 2020 with 4.

0% of its events are Class I; the most common class is Class II (5). 0 events are listed as ongoing; the recalling firm's address is in VT.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
6 Dec 2021	ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-0637-03	Drug	Class II	56	Terminated
12 Apr 2021	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	Drug	Class II	1	Terminated
17 Feb 2021	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	Drug	Class III	1	Terminated
22 Dec 2020	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	Drug	Class III	1	Terminated
2 Jul 2020	Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 NDC 05446-1458-01	Drug	Class II	1	Terminated
19 Mar 2020	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	Drug	Class II	1	Terminated
19 Mar 2020	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 is a compounded (re-packaged) drug. Not…	Drug	Class II	1	Terminated

By type and class

Drug7

Class II5

Class III2

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Edge Pharma, LLC by year initiated.

Questions and answers

How many FDA recalls has Edge Pharma, LLC had?

7 enforcement events (62 product records) on this register, 2020–2021: 7 drug.

Are any Edge Pharma, LLC recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Edge Pharma, LLC recalls?

5 Class II, 2 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.