CLASS III Drug recall · Reported 16 Apr 2014 · FDA Enforcement Report
Spiriva HandiHaler (tiotropium bromide inhalation powder) recalled
Boehringer Ingelheim Roxane is recalling Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva, distributed nationwide in the US. The recall was initiated on 27 Mar 2014 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-1230-2014
- FDA event ID
- 67796
- Recalling firm
- Boehringer Ingelheim Roxane, Columbus, OH
- Brand
- Spiriva
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 Mar 2014
- FDA classified
- 10 Apr 2014
- Reported
- 16 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Inhalers & Asthma Medication
Timeline
| 27 Mar 2014 | Recall initiated by company | |
| 10 Apr 2014 | Classified by FDA | +14 days |
| 16 Apr 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.
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), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only, 18 mcg (as tiotropium) per capsule, Rx Only, a) NDC 0597-0075-75, 5 Spiriva capsules per blister card, b) NDC 0597-0075-41, 30 Spiriva capsules per blister card, Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany, Marketed by: Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT 06877 USA and Pfizer Inc New York, NY 10017 USA, Made in Germany.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.
Which lots are affected?
a) 5 count capsule blister card: 303012A, Exp Sep 2014; b) 30 count capsules blister card: 303012B, Exp Sep 2014, 303125A, 303253A, Exp Oct 2014, 303895A, 304282A, Exp Nov 2014, 304510A, Exp Dec 2014
Where was it sold?
Nationwide and Puerto Rico
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 21 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 Roxane
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|---|---|---|---|---|---|
| Drug | CLASS III | Furosemide Tablets USP, 40 mg recalled by Boehringer Ingelheim RoxaneFurosemide | Boehringer Ingelheim Roxane | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Furosemide Tablets USP, 20 mg recalled by Boehringer Ingelheim RoxaneFurosemide | Boehringer Ingelheim Roxane | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Combivent Respimat (ipratropium bromide recalledCombivent Respimat | Boehringer Ingelheim Roxane | Other | Nationwide |
| Drug | CLASS II | Acarbose Tablets 50 mg a) Unit Dose Tablets per, b) recalledAcarbose | Boehringer Ingelheim Roxane | Potency & Assay | Nationwide |
| Drug | CLASS III | Oxycodone Hydrochloride C II Oral Solution USP, 5 mg/ Vial recalled | Boehringer Ingelheim Roxane | Potency & Assay | Nationwide |
Other Tiotropium Bromide recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder) recalledSpiriva | Boehringer Ingelheim Roxane | Particulate Matter | Nationwide |