The Recall Desk

Manufacturer

Novitium Pharma LLC

6 recalls in our database name Novitium Pharma LLC as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
4
Most recent
2024-04-24

Of the 6 recalls from Novitium Pharma LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (67%) 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-0443-2024·2024-04-24

    Digoxin Tablets Recalled Due to Failed Impurity and Degradation Specifications

    Novitium Pharma LLC is recalling 1,003 bottles of Digoxin tablets (Lot M23011A, expiring 12/2024) distributed nationwide due to failed impurity and degradation specifications. Patients should consult their healthcare provider immediately.

    Product
    DIGOXIN — DIGOXIN (DIGOXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0389-2024·2024-03-27

    Digoxin Tablets Recalled Due to Cross Contamination with Mycophenolate Mofetil

    Novitium Pharma LLC recalls Digoxin 125mcg tablets nationwide due to cross contamination with mycophenolate mofetil, a different medication. Patients receiving contaminated tablets could experience unintended drug effects.

    Product
    DIGOXIN — DIGOXIN (DIGOXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0313-2020·2019-11-20

    Novitium Pharma Recalls Ranitidine Capsules Due to NDMA Impurity

    Novitium Pharma LLC is recalling Ranitidine Capsules 300 mg because of the presence of the NDMA impurity. The recall covers 6,660 bottles distributed nationwide.

    Product
    Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0311-2020·2019-11-20

    Novitium Pharma Recalls Ranitidine Capsules Due to NDMA Impurity

    Novitium Pharma LLC is recalling 2,718 bottles of Ranitidine Capsules 150 mg because the product contains the NDMA impurity.

    Product
    Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0312-2020·2019-11-20

    Novitium Pharma Recalls Ranitidine Capsules Due to NDMA Impurity

    Novitium Pharma LLC is recalling Ranitidine Capsules 300 mg because the product was found to contain the NDMA impurity.

    Product
    Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0310-2020·2019-11-20

    Novitium Pharma Recalls Ranitidine Capsules Due to NDMA Impurity

    Novitium Pharma LLC is recalling 19,560 bottles of Ranitidine Capsules 150 mg nationwide because the product contains the NDMA impurity.

    Product
    Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-20
    Category
    Drug
    Distribution
    Distributed nationwide