CLASS III Drug recall · Reported 25 Sep 2013 · FDA Enforcement Report
Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder) recalled
Boehringer Ingelheim Roxane is recalling Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, distributed nationwide in the US. The recall was initiated on 30 Aug 2013 and the FDA has classified it as Class III.
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-1057-2013
- FDA event ID
- 65428
- Recalling firm
- Boehringer Ingelheim Roxane, Columbus, OH
- Brand
- Spiriva
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 30 Aug 2013
- FDA classified
- 16 Sep 2013
- Reported
- 25 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Inhalers & Asthma Medication
Timeline
| 30 Aug 2013 | Recall initiated by company | |
| 16 Sep 2013 | Classified by FDA | +17 days |
| 25 Sep 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA Handihaler
Product as listed by the FDA
SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 count blister (NDC 0597-0075-27), b) 30 count blister (NDC 0597-0075-41), c) 90 count blister (NDC 0597-0075-47), d) 5 count blister physician sample (NDC 0597-0075-75), Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA Handihaler
Which lots are affected?
Lot Number/Exp. Date: 202477A/Sep-13, 202480A/Sep-13, 202556B/Sep-13, 202603A/Sep-13, 202784B/Sep-13, 202844A/Sep-13, 202951A/Sep-13, 203041A/Sep-13, 203042A,Sep-13, 203280A/Oct-13, 203281A/Oct-13, 203364A/Oct-13, 203440A,Oct-13, 203569B/Oct-13, 203588A/Oct-13, 203890B/Nov-13, 204094A/Nov-13, 203660A/Nov-13, 203690A/Nov-13, 203890A/Nov-13, 203980A/Nov-13, 203981B/Nov-13, 204356B/Dec-13, 204357A/Dec-13, 204821A/Dec-13, 204459A/Dec-13, 204552C/Dec-13, 204822A/Dec-13, 204944A/Jan-14, 204947A/Jan-14, 205015A/Jan-14, 205163A/Jan-14, 205364A/Jan-14, 205509A/Feb-14, 205737A/Feb-14, 205571A/Feb-14, 205572A/Feb-14, 205674A/Feb-14, 205682A/Feb-14, 205959A/Feb-14, 205987A/Feb-14, 206186B/Mar-14, 206311A/Mar-14, 206606A/Mar-14, 206944B/Apr-14, 207066A/Apr-14, 206609A/Apr-14, 206729A/Apr-14, 206899A/Apr-14, 206900A/ Apr-14, 207065B/Apr-14, 207191A/May-14, 207199A/May-14, 207352A/May-14, 207420A/May-14, 207577B/May-14, 207691A/May-14, 207692A/May-14, 207778A/May-14, 207818A/Jun-14, 301378A/Jul-14, 301476B/Jul-14, 301699B/Jul-14, 301867A/Aug-14, 202530/Sep-13, 203195A/Oct-13, 203366C/Nov-13, 204067A/Nov-13, 204460B/Dec-13, 204551A/Dec-13, 205260A/Jan-14, 206064B/Mar-14, 206185A/Mar-14, 206939A/Apr-14, 207038A/May-14, 301699A/Jul-14, 202556A/Sep-13, 203569A/Oct-13, 203981A/Nov-13, 204674A/Dec-13, 205737B/Feb-14, 206944A/Apr-14, 207577A/May-14, 301476A/Jul-14 Physician Drug Samples: 203076A/Oct-13, 203891A/Nov-13, 204674B/Dec-13, 205867A/Feb-14, 206731A/Apr-14
Where was it sold?
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
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|---|---|---|---|---|---|
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Other 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 II | Spiriva HandiHaler (tiotropium bromide inhalation powder) recalledSpiriva | Boehringer Ingelheim Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Spiriva HandiHaler (tiotropium bromide inhalation powder) recalledSpiriva | Boehringer Ingelheim Roxane | Potency & Assay | Nationwide |