The Recall Desk

Manufacturer

Amneal Pharmaceuticals

1 recall in our database name Amneal Pharmaceuticals as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
1
Most recent
2018-04-04

Of the 1 recalls from Amneal Pharmaceuticals we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (100%) 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

  • SevereFDA (Drugs)·D-0610-2018·2018-04-04

    Amneal Recalls Fosphenytoin Sodium Injection Due to Particulate Matter

    Amneal Pharmaceuticals is recalling specific lots of Fosphenytoin Sodium Injection because of the presence of particulate matter.

    Product
    Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1
    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.

Amneal Pharmaceuticals, Inc.

American publicly traded generics and specialty pharmaceutical company

Country
United States

Official website

Source: Wikidata (Q16996714), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.