The Recall Desk

Manufacturer

Ingenus Pharmaceuticals Llc

6 recalls in our database name Ingenus Pharmaceuticals Llc as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
2
Most recent
2022-10-26

Of the 6 recalls from Ingenus Pharmaceuticals Llc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (33%) 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.

1–6 of 6

  • ModerateFDA (Drugs)·D-0010-2023·2022-10-26

    FDA Recalls Flunisolide Nasal Solution Due to Out-of-Specification Impurities

    Ingenus Pharmaceuticals is recalling Flunisolide Nasal Solution nationwide because the product contains impurities that exceed acceptable limits. The recall affects two lots distributed across the United States.

    Product
    FLUNISOLIDE — FLUNISOLIDE (FLUNISOLIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0374-2022·2022-01-26

    Clobetasol Propionate Foam Recalled for CGMP Deviations

    Ingenus Pharmaceuticals is recalling 45,173 cans of Clobetasol Propionate Foam, 0.05%, nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary, FDA Class II recall.

    Product
    Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0146-2020·2019-10-23

    Ingenus Recalls Leucovorin Calcium Injection Due to Crystallization

    Ingenus Pharmaceuticals is recalling Leucovorin Calcium Injection vials due to the presence of particulate matter identified as API crystallization.

    Product
    Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Orlando, FL 32839
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1058-2019·2019-04-03

    Ingenus Recalls Diclofenac Sodium Topical Solution Due to Leaking Bottles

    Ingenus Pharmaceuticals is recalling 29,435 bottles of Diclofenac Sodium Topical Solution because some bottles were found leaking.

    Product
    Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0890-2018·2018-07-11

    Ingenus Recalls Irinotecan Hydrochloride Injection Due to Potency Issues

    Ingenus Pharmaceuticals is recalling specific lots of Irinotecan Hydrochloride Injection because they had high out-of-specification assay values for potency.

    Product
    IRINOTECAN HYDROCHLORIDE — IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0891-2018·2018-07-11

    Ingenus Recalls Irinotecan Hydrochloride Injection Due to Potency Issues

    Ingenus Pharmaceuticals is recalling Irinotecan Hydrochloride Injection because of high out-of-specification assay values for potency.

    Product
    IRINOTECAN HYDROCHLORIDE — IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide