The Recall Desk

Manufacturer

Novel Laboratories, Inc.

3 recalls in our database name Novel Laboratories, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2018-03-21

Of the 3 recalls from Novel Laboratories, Inc. we have scored against our rubric, 0 (0%) 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.

1–3 of 3

  • ModerateFDA (Drugs)·D-0599-2018·2018-03-21

    Novel Laboratories Recalls Hydrocodone Bitartrate and Homatropine Methylbromide Tablets

    Novel Laboratories is recalling specific lots of Hydrocodone Bitartrate and Homatropine Methylbromide tablets due to failed impurities and degradation specifications.

    Product
    HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE — HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1484-2014·2014-09-03

    Novel Laboratories Recalls Famotidine Oral Suspension Due to Impurity Failure

    Novel Laboratories is recalling 25,776 containers of Famotidine Oral Suspension because the product failed an impurity specification. The recall is classified as FDA Class III.

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