Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per Recalled by Boehringer Ingelheim Roxane Inc Due to Presence of Foreign Substance: This recall is being...
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) 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
Quantity: 15,385,232 capsules
Why Was This 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
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