Recall Register

Food, drugs, devices › Firms

X-Gen Pharmaceuticals Inc.

FDA recalling firm · 7 enforcement events · 8 product records · 2014–2024 · NY

X-Gen Pharmaceuticals Inc. has 7 FDA enforcement events on this register (8 product records) between 2014 and 2024: 7 drug; the busiest year was 2017 with 2.

14% of its events are Class I; the most common class is Class III (4). 0 events are listed as ongoing; the recalling firm's address is in NY.

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

InitiatedProduct (first record)TypeClassRecordsStatus
2 Apr 2024Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC # 39822-0250-01.DrugClass III2Terminated
19 Mar 2021Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14814. NDC 39822-0310-5DrugClass II1Terminated
11 Oct 2019Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limited Pilot No. 14, Sipcot II, Hosur-635 109 Tamil Nadu, India, Manufactured for: X-Gen Pharmaceuticals, Inc. Big Flats, NY 14814, NDC 39822-4000-1DrugClass III1Terminated
29 Mar 2019Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals, Big Flats, NY 14814, NDC 39822-2000-1.DrugClass III1Terminated
17 May 2017Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61DrugClass II1Terminated
8 Feb 2017Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-1030-1), packaged in 3 x 2 mL Single-Dose Vials per carton (NDC 39822-1030-2); Rx only, Distributed by: X-Gen Pharmaceuticals, Inc., Big Flats, NY 14814; Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.DrugClass I1Terminated
17 Jul 2014Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big Flats, NY 14814, NDC 39822-2000-1.DrugClass III1Terminated

By type and class

Drug7
Class III4
Class II2
Class I1

Class I: 14% of this firm's events; 18% of all events on the register.

Events by year

14
16
18
20
22
24
26
Enforcement events for X-Gen Pharmaceuticals Inc. by year initiated.

Questions and answers

How many FDA recalls has X-Gen Pharmaceuticals Inc. had?

7 enforcement events (8 product records) on this register, 2014–2024: 7 drug.

Are any X-Gen Pharmaceuticals Inc. recalls ongoing?

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

What class are X-Gen Pharmaceuticals Inc. recalls?

4 Class III, 2 Class II, 1 Class I. 14% 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.