The Recall Desk

Manufacturer

Elite Laboratories Inc.

1 recall in our database name Elite Laboratories Inc. as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2017-12-13

Of the 1 recalls from Elite 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.

1–1 of 1

  • ModerateFDA (Drugs)·D-0107-2018·2017-12-13

    Elite Laboratories Recalls Isradapine Capsules Due to Impurity Failures

    Elite Laboratories Inc. is recalling 1,264 bottles of Isradapine Capsules USP 2.5 mg in New York due to failed impurities and degradation specifications.

    Product
    Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc. Northvale, NJ 07647, NDC 42806-263-01, UPC 342806263013
    Category
    Drug
    Distribution
    1 state