Boehringer Ingelheim Pharmaceuticals, Inc. recalls SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx
Boehringer Ingelheim recalls SPIRIVA HandiHaler inhalers with failed stability specifications. This may affect safety and effectiveness of the medication.
Lower-risk recall
Failed Stability Specifications
Contact the company & request your remedy
What happened, in plain English
Boehringer Ingelheim is recalling SPIRIVA HandiHaler inhalers that failed stability tests. This could mean the medication might not work as intended or become unsafe over time. Read more at govinfonow.com/recall/41017-boehringer-ingelheim-spiriva-handihaler-18mcg-recall-failed-stability-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/41017-boehringer-ingelheim-spiriva-handihaler-18mcg-recall-failed-stability-specifications · Updated October 7, 2026 · FDA enforcement record: FDA #D-0242-2018
Cite this page
“Boehringer Ingelheim SPIRIVA HandiHaler 18mcg recall: Failed stability specifications.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41017-boehringer-ingelheim-spiriva-handihaler-18mcg-recall-failed-stability-specifications. Based on FDA recall #D-0242-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0242-2018%22&limit=1).
Why it’s dangerous
The inhaler failed stability tests, meaning the medication could degrade over time. This might reduce effectiveness or cause unexpected reactions if the product is not stored properly.
Who’s affected
People with a prescription for SPIRIVA HandiHaler 18 mcg/capsule (90 capsules per box) who bought it between 2017 and 2018 are affected. Those with respiratory conditions like COPD are at higher risk.
How to tell if you have this one
Check for the product name SPIRIVA HandiHaler, 18 mcg/capsule, 90 capsules per box, and the lot number 606478. It was distributed by Boehringer Ingelheim and expires March 2018.
- Brand
Boehringer Ingelheim- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number 606478 and expiration date of March 2018 on the packaging.
Questions people ask
Is this product safe to use?
The recall is due to failed stability tests, which may affect effectiveness but does not indicate immediate danger. Consult your doctor for advice.
How do I know if I have the recalled product?
Check for the lot number 606478 and expiration date of March 2018 on the SPIRIVA HandiHaler packaging.
What should I do if I have this product?
The recall does not specify a remedy, so contact your doctor or pharmacist for guidance on whether to continue using it.
Contact Boehringer Ingelheim
We’ve drafted a message you can send Boehringer Ingelheim to request your refund or repair — edit it as you like.
Subject: Recall D-0242-2018 — Boehringer Ingelheim Boehringer Ingelheim Hello, I own a Boehringer Ingelheim that is covered by recall D-0242-2018 from Boehringer Ingelheim. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0242-2018 (December 14, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0242-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.