The Recall Desk

Manufacturer

X-Gen Pharmaceuticals Inc.

8 recalls in our database name X-Gen Pharmaceuticals Inc. as the manufacturing or recalling firm.

What the numbers show

Total
8
Critical
1
Severe
0
Most recent
2024-04-10

Of the 8 recalls from X-Gen Pharmaceuticals Inc. we have scored against our rubric, 1 (13%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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.

1–8 of 8

  • ModerateFDA (Drugs)·D-0433-2024·2024-04-10

    Cyclophosphamide Injection Recalled for Package Insert Concentration Labeling Error

    X-Gen Pharmaceuticals is recalling 1,283 vials of Cyclophosphamide for Injection due to a Package Insert error that lists concentration as '20 mg per vial' instead of '20 mg per mL'. No illnesses have been reported.

    Product
    Cyclophosphamide 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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0434-2024·2024-04-10

    Cyclophosphamide Injection Recalled for Package Insert Concentration Labeling Error

    X-Gen Pharmaceuticals recalls Cyclophosphamide for Injection due to a labeling error in the Package Insert. Section 2.3 incorrectly lists the concentration as '20 mg per vial' instead of the correct '20 mg per mL'.

    Product
    Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted before intravenous infusion, Rx Only, Manufactured for: XGen Pharmaceuticals DJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0328-2021·2021-04-14

    X-Gen Recalls Neomycin Sulfate Tablets Due to Microbiological Failure

    X-Gen Pharmaceuticals is recalling Neomycin Sulfate Tablets 500mg because a microbiological assay failed to meet stability specifications.

    Product
    Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14814. NDC 39822-0310-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0519-2020·2019-11-27

    X-Gen Pharmaceuticals Recalls Levetiracetam Injection Due to Incorrect Package Insert

    X-Gen Pharmaceuticals is recalling Levetiracetam Injection vials because the incorrect package insert version was attached to the product.

    Product
    Levetiracetam 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 39822-4000-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1084-2019·2019-04-17

    X-Gen Recalls Clonidine Injection Vials Due to Labeling Error

    X-Gen Pharmaceuticals is recalling Clonidine HCL Injection vials because the side carton incorrectly lists the concentration as 500 mcg instead of 100 mcg per mL.

    Product
    CLONIDINE — CLONIDINE (CLONIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1059-2017·2017-08-16

    X-Gen Recalls Nystatin Topical Powder Due to Potential Plastic Particles

    X-Gen Pharmaceuticals is recalling Nystatin Topical Powder due to the potential presence of plastic particles. The recall covers 9,816 bottles distributed nationwide.

    Product
    Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0637-2017·2017-04-12

    X-Gen Recalls Ibuprofen Lysine Injection Due to Particulate Matter

    X-Gen Pharmaceuticals is recalling 2,593 cartons of Ibuprofen Lysine Injection because of the presence of particulate matter. The affected product was distributed nationwide in the USA.

    Product
    IBUPROFEN LYSINE — IBUPROFEN LYSINE (IBUPROFEN LYSINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1444-2014·2014-07-30

    X-Gen Recalls Clonidine HCl Injection Due to Labeling Error

    X-Gen Pharmaceuticals is recalling Clonidine HCl Injection vials because the side label incorrectly states the drug strength.

    Product
    CLONIDINE — CLONIDINE (CLONIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide