CLASS II Drug recall · Reported 7 Feb 2018 · FDA Enforcement Report
Spiriva HandiHaler (tiotropium bromide inhalation powder) recalled
Boehringer Ingelheim Pharmaceuticals is recalling Spiriva HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (unit dose, distributed nationwide in the US. The recall was initiated on 14 Dec 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0242-2018
- FDA event ID
- 78775
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT
- Brand
- Spiriva
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Dec 2017
- FDA classified
- 26 Jan 2018
- Reported
- 7 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Inhalers & Asthma Medication
Timeline
| 14 Dec 2017 | Recall initiated by company | |
| 26 Jan 2018 | Classified by FDA | +43 days |
| 7 Feb 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in Germany, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0075-47
Where it was distributed
Distributed nationwide
Questions about this recall
Why was it recalled?
Failed Stability Specifications
Which lots are affected?
Lot # 606478; Exp. 03/18
Where was it sold?
Distributed nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Boehringer Ingelheim Pharmaceuticals
All 13Other Tiotropium recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Spiriva Handihaler (tiotropium bromide inhalation powder) recalledSpiriva | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Spiriva HandiHaler (tiotropium bromide inhalation powder) recalledSpiriva | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS III | Spiriva HandiHaler (tiotropium bromide inhalation powder) recalledSpiriva | Boehringer Ingelheim Roxane | Potency & Assay | Nationwide |
| Drug | CLASS III | Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder) recalledSpiriva | Boehringer Ingelheim Roxane | Particulate Matter | Nationwide |