Spiriva recalls

Spiriva products have been recalled 5 times, most recently on 3 Jan 2024. The recalling company is usually Boehringer Ingelheim Roxane. The most common reason is manufacturing (cgmp) deviations.

Total recalls5since 2013

Last 12 months0reported

Class I00% of total

Ongoing0latest 3 Jan 2024

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 3 60%Class III 2 40%

Why spiriva is recalled

Companies

Boehringer Ingelheim Roxane240%
Boehringer Ingelheim Pharmaceuticals120%
Cardinal Health120%
Cardinal Healthcare120%

Product types

Inhalers & Asthma Medication5100%

By year

2024120%
2021120%
2018120%
2014120%
2013120%

All spiriva recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
3 Jan 2024Drug	CLASS II	Spiriva Handihaler (tiotropium bromide inhalation powder) recalledSpiriva	Cardinal Healthcare	Manufacturing (CGMP) Deviations	Nationwide
2 Jun 2021Drug	CLASS II	Spiriva HandiHaler (tiotropium bromide inhalation powder) recalledSpiriva	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
7 Feb 2018Drug	CLASS II	Spiriva HandiHaler (tiotropium bromide inhalation powder) recalledSpiriva	Boehringer Ingelheim Pharmaceuticals	Potency & Assay	Nationwide
16 Apr 2014Drug	CLASS III	Spiriva HandiHaler (tiotropium bromide inhalation powder) recalledSpiriva	Boehringer Ingelheim Roxane	Potency & Assay	Nationwide
25 Sep 2013Drug	CLASS III	Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder) recalledSpiriva	Boehringer Ingelheim Roxane	Particulate Matter	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.