The Recall Desk

Manufacturer

Impax Laboratories, Inc.

5 recalls in our database name Impax Laboratories, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
3
Most recent
2016-12-28

Of the 5 recalls from Impax 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 3 (60%) 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.

1–5 of 5

  • SevereFDA (Drugs)·D-0215-2017·2016-12-28

    Impax Recalls Lamotrigine Tablets Due to Labeling Mixup

    Impax Laboratories is recalling 3,074 boxes of Lamotrigine Orally Disintegrating Tablets because some 200 mg boxes contained 100 mg tablets.

    Product
    Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0825-2016·2016-04-27

    Impax Recalls Dextroamphetamine Sulfate Tablets Due to Failed Impurity Specifications

    Impax Laboratories is recalling 67,428 bottles of Dextroamphetamine Sulfate Tablets USP, 10 mg, because the product failed impurities and degradation specifications.

    Product
    Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0826-2016·2016-04-27

    Impax Recalls Dextroamphetamine Sulfate Tablets Due to Failed Impurity Specifications

    Impax Laboratories is recalling specific lots of Dextroamphetamine Sulfate Tablets because they failed impurity and degradation specifications.

    Product
    Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0820-2016·2016-04-20

    Impax Recalls Fenofibrate Capsules Due to Incorrect or Missing Labeling

    Impax Laboratories is recalling 28,001 bottles of Fenofibrate Capsules (Micronized) 134 mg because the bottles have incorrect or missing lot and expiration dates.

    Product
    Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0821-2016·2016-04-20

    Impax Recalls Fenofibrate Capsules Due to Incorrect or Missing Labeling

    Impax Laboratories is recalling 42,239 bottles of Fenofibrate Capsules (Micronized) 200 mg because some bottles have incorrect or missing lot and expiration dates.

    Product
    Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02
    Category
    Drug
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Impax Laboratories Inc

pharmaceutical company

Country
United States
Founded
1995

Official website

Source: Wikidata (Q104705751), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.