Tudorza Pressair Recall: Defective Actuation Counter
AstraZeneca recalls Tudorza Pressair inhalers because the actuation counter may display an incorrect number of doses, affecting medication tracking.
Use caution until it’s fixed
Defective Delivery System: Some units have actuation counters set to a number other than 60.
Contact the company
What happened, in plain English
AstraZeneca Pharmaceuticals LP is recalling specific lots of Tudorza Pressair (aclindinium bromide) inhalers due to a defective delivery system. The issue involves actuation counters that are set to a number other than the correct 60 metered doses. This defect means patients may not know exactly how many doses remain in their device. Read more at govinfonow.com/recall/43167-tudorza-pressair-recall-defective-actuation-counter.
Source Summary by GovInfoNow · govinfonow.com/recall/43167-tudorza-pressair-recall-defective-actuation-counter · Updated October 11, 2026 · FDA enforcement record: FDA #D-0781-2016
Cite this page
“Tudorza Pressair Recall: Defective Actuation Counter.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43167-tudorza-pressair-recall-defective-actuation-counter. Based on FDA recall #D-0781-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0781-2016%22&limit=1).
Why it’s dangerous
The actuation counter on some units displays an incorrect number instead of 60. This can lead to patients being unsure if they have received their full prescribed dose or if the inhaler is empty, potentially affecting their treatment adherence.
Who’s affected
Patients prescribed Tudorza Pressair for respiratory conditions who purchased the affected inhalers nationwide, including Puerto Rico. Users of the specific lots listed are at risk of inaccurate dose tracking.
How to tell if you have this one
Check your Tudorza Pressair inhaler for NDC 0310-0800-60 and look at the lot number on the packaging. Affected lots are 1144394 (Expiry 04/2018), 1145539 (Expiry 04/2018), and 1145868 (Expiry 05/2018). The product was distributed nationwide in the US including Puerto Rico.
- Brand
Tudorza Pressair- Category
Drug
What to do — step by step
Check Your Lot Number
Verify if your inhaler matches one of the recalled lot numbers: 1144394, 1145539, or 1145868.
Contact Your Pharmacist
Reach out to your pharmacy or healthcare provider to discuss how to handle the defective counter and obtain a replacement if necessary.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US: Nationwide Including Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0781-2016 (February 5, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0781-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.