Spiriva HandiHaler (Boehringer) – Delivery System Issue (2014)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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 Ge
Brand
Boehringer Ingelheim Roxane Inc
Lot Codes / Batch Numbers
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
Products Sold
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
Boehringer Ingelheim Roxane Inc is recalling Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use due to Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the int. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026