The Recall Desk

Manufacturer

Chiesi USA, Inc.

4 recalls in our database name Chiesi USA, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
1
Most recent
2026-07-22

Of the 4 recalls from Chiesi USA, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (25%) 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.

1–4 of 4

  • SevereFDA (Drugs)·D-0689-2026·2026-07-22

    Cleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns

    Chiesi USA, Inc. is recalling Cleviprex (clevidipine) injectable emulsion due to lack of assurance of sterility. The affected product is distributed nationwide.

    Product
    CLEVIPREX — CLEVIPREX (CLEVIPIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1342-2019·2019-06-19

    Chiesi Recalls Zileuton Extended-Release Tablets Due to Dissolution Failure

    Chiesi USA is recalling 2,598 bottles of Zileuton Extended-Release Tablets, 600 mg, because they failed dissolution specifications.

    Product
    Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1341-2019·2019-06-19

    Chiesi Recalls ZYFLO CR Tablets Due to Dissolution Failure

    Chiesi USA is recalling ZYFLO CR (zileuton) extended-release tablets because they failed to meet dissolution specifications. The recall affects 2,118 bottles distributed nationwide.

    Product
    ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-902-12.
    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.

Chiesi

Country
Germany
Founded
2002
Parent company
Chiesi Farmaceutici S.p.A.

Official website

Source: Wikidata (Q26883009), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.