Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Spiriva HandiHaler (tiotropium bromide inhalation powder) Recalled by Boehringer Ingelheim Roxane Inc Due to Defective Delivery System: Potential for dose delivery out...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Boehringer Ingelheim Roxane Inc directly.
Affected Products
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.
Quantity: 1,276,710 Blister Cards
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Boehringer Ingelheim Roxane Inc
Boehringer Ingelheim Roxane Inc has 15 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report