The Recall Desk

Manufacturer

Janssen Ortho L.L.C.

2 recalls in our database name Janssen Ortho L.L.C. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
1
Most recent
2016-11-02

Of the 2 recalls from Janssen Ortho L.L.C. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (50%) 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.

1–2 of 2

  • LowFDA (Drugs)·D-0115-2017·2016-11-02

    Invokamet Recalled for Incorrect or Missing Package Insert Labeling

    Janssen Ortho L.L.C. is recalling Invokamet tablets because Xarelto prescribing information outserts may be affixed to the bottles instead of the correct Invokamet inserts.

    Product
    INVOKAMET — INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0006-2015·2014-10-15

    Janssen Recalls Xarelto Tablets Due to Microbial Contamination

    Janssen Ortho L.L.C. is recalling 13,500 bottles of Xarelto (rivaroxaban) 15 mg tablets due to confirmed microbial contamination in a sales sample.

    Product
    Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
    Category
    Drug
    Distribution
    Distributed nationwide