Mallinckrodt recalls

Mallinckrodt has 6 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 21 Sep 2022. 1 is still ongoing. The most frequent reason is packaging defects.

Total recalls6since 2012

Last 12 months0reported

Class I00% of total

Ongoing1latest 21 Sep 2022

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 4 67%Class III 2 33%

Why mallinckrodt is recalled

Product types

By year

2022117%
2015117%
2012467%

Ongoing mallinckrodt recalls

1 active

Reported	Class	Recall	Company	Reason	Where
21 Sep 2022Device	CLASS II	INOmax Dsir -(delivery system) delivers Inomax recalled by Mallinckrodt	Mallinckrodt	Device Malfunction	NJ

All mallinckrodt recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
21 Sep 2022Device	CLASS II	INOmax Dsir -(delivery system) delivers Inomax recalled by Mallinckrodt	Mallinckrodt	Device Malfunction	NJ
17 Jun 2015Drug	CLASS II	MD-Gastroview (Diatrizoate Meglumine recalled by MallinckrodtMd Gastroview	Mallinckrodt	Other	MO
3 Oct 2012Drug	CLASS III	Thallous Chloride Tl 201 Injection, Diagnostic Sterile recalled	Mallinckrodt	Packaging Defects	11 states
8 Aug 2012Drug	CLASS III	Hydrocodone Bitartrate and Acetaminophen Oral Solution recalled	Mallinckrodt	Potency & Assay	Nationwide
8 Aug 2012Drug	CLASS II	Hydrocodone Bitartrate and Acetaminophen Oral Solution recalled	Mallinckrodt	Manufacturing (CGMP) Deviations	Nationwide
1 Aug 2012Device	CLASS II	The Handi-Fil Disposable Syringe Fill Tube is a sterile recalled	Mallinckrodt	Packaging Defects	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.