The Recall Desk

Manufacturer

Shionogi Inc.

5 recalls in our database name Shionogi Inc. as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2018-01-24

Of the 5 recalls from Shionogi 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.

1–5 of 5

  • LowFDA (Drugs)·D-0219-2018·2018-01-24

    Shionogi Recalls Mefenamic Acid Capsules Due to Foreign Particles

    Shionogi Inc. is recalling 968 bottles of Mefenamic Acid Capsules, 250 mg, due to the presence of black particles found during routine stability testing.

    Product
    Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ 07981, NDC 66993-070-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0982-2017·2017-07-26

    Shionogi Recalls PONSTEL Capsules Due to Failed Dissolution Specifications

    Shionogi Inc. is recalling 455 bottles of PONSTEL capsules because stability testing showed low dissolution results.

    Product
    PONSTEL (Mefanamic Acid) USP, 250 mg capsules, 30-count bottles, Rx Only, Manufactured for: Shionogi Inc. Florham Park, NJ 07932 Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0981-2017·2017-07-26

    Shionogi Recalls Mefenamic Acid Capsules for Dissolution Failures

    Shionogi Inc. is recalling Mefenamic Acid 250mg capsules because stability testing showed low dissolution results.

    Product
    Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distributed by: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981, NDC 66993-070-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1398-2012·2012-07-04

    Shionogi Recalls Nisoldipine Extended Release Tablets for Dissolution Failure

    Shionogi Inc. is recalling Nisoldipine Extended Release Tablets, 17mg, because a specific lot failed USP dissolution testing requirements.

    Product
    Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured by SkyePharma production SAS 38297, Saint Quentin-Pallavier, France, NDC: 0677-1979-01
    Category
    Drug
    Distribution
    1 state

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.

Shionogi

Japanese pharmaceutical company

Country
Japan
Founded
1919

Official website

Source: Wikidata (Q3482319), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.