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Shire

FDA Regulatory Profile

Shire has 3 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Shire". They do not include records filed under Takeda or other names in its corporate family; those are listed under Related names, each with its own counts.

Latest recall: D-0625-2017 · Class II · Mar 17, 2017
Latest inspection: Apr 9, 2018 · NAI

Part of the Takeda corporate family.

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	3	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	5	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Shire's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	Recall records
2026	0	0
2025	0	0
2024	0	0
2023	0	0
2022	0	0
2021	0	0
2020	0	0
2019	0	0
2018	1	0
2017	0	1

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for Shire above. Takeda is the parent company.

Name	Relation	Recalls	510(k)	Inspections	Compliance actions	Most recent recall
Takeda	parent company	0	0	7	0	—

Recent recalls

3 recall records from Sep 2, 2016 to Mar 17, 2017.

Number	Class	Product	Date
D-0625-2017	Class II	Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington…	Mar 17, 2017
D-0432-2017	Class III	Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured…	Dec 2, 2016
D-0006-2017	Class III	Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx Only, Manufactured for…	Sep 2, 2016

Recent FDA inspections

5 inspections from Aug 5, 2009 to Apr 9, 2018.

Date	Site	Product	Classification	FEI
Apr 9, 2018	Lexington, MA	Drugs	No Action Indicated (NAI)	3013975505
Jun 25, 2014	Florence, KY	Drugs	No Action Indicated (NAI)	3004216362
Dec 2, 2010	Chesterbrook, PA	Drugs	Voluntary Action Indicated (VAI)	3001237683
Apr 22, 2010	Chesterbrook, PA	Drugs	Voluntary Action Indicated (VAI)	3001237683
Aug 5, 2009	Chesterbrook, PA	Drugs	No Action Indicated (NAI)	3001237683

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

3 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3013975505	Lexington, MA	1	Apr 9, 2018
FEI 3004216362	Florence, KY	1	Jun 25, 2014
FEI 3001237683	Chesterbrook, PA	3	Dec 2, 2010

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