Recall Register

Food, drugs, devices › Firms

Shionogi Inc.

FDA recalling firm · 4 enforcement events · 5 product records · 2012–2017 · GA

Shionogi Inc. has 4 FDA enforcement events on this register (5 product records) between 2012 and 2017: 4 drug; the busiest year was 2017 with 2.

0% of its events are Class I; the most common class is Class III (3). 0 events are listed as ongoing; the recalling firm's address is in GA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
24 May 2017Mefenamic 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 66993-070-30DrugClass III1Terminated
24 May 2017Mefenamic 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 66993-070-30DrugClass III2Terminated
24 Jul 2015Nisoldipine Extended Release Tablets, 17 mg, packaged as a) Sular (nisoldipine) Extended Release tablets, 100-count bottle (NDC 59630-501-10, UPC 3 59630 50110 5), Manufactured for: Shionogi, Inc., Florham Park, NJ 07932; and b) Nisoldipine Extended Release tablets, 100-count bottle (NDC 66993-473-02, UPC 3 6693…DrugClass III1Terminated
8 Mar 2012Nisoldipine 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: 0677-1979-01DrugClass II1Terminated

By type and class

Drug4
Class III3
Class II1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

12
14
16
18
20
22
24
26
Enforcement events for Shionogi Inc. by year initiated.

Questions and answers

How many FDA recalls has Shionogi Inc. had?

4 enforcement events (5 product records) on this register, 2012–2017: 4 drug.

Are any Shionogi Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Shionogi Inc. recalls?

3 Class III, 1 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.