Teva AirDuo Digihaler 55/14 Inhaler Recall: Subpotent Salmeterol Risk
Teva recalls AirDuo Digihaler 55/14 inhalers due to potential subpotent salmeterol levels. This may result in less effective treatment for asthma. Affected units have NDC 59310-111-06 and were manufactured in Ireland.
Lower-risk recall
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
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What happened, in plain English
Teva is recalling AirDuo Digihaler 55/14 inhalers because lab tests show they may contain less salmeterol than labeled. This could mean the inhaler isn't as effective for asthma treatment as it should be. Read more at govinfonow.com/recall/35842-teva-airduo-digihaler-55-14-inhaler-recall-subpotent-salmeterol-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/35842-teva-airduo-digihaler-55-14-inhaler-recall-subpotent-salmeterol-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0023-2022
Cite this page
“Teva AirDuo Digihaler 55/14 Inhaler Recall: Subpotent Salmeterol Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35842-teva-airduo-digihaler-55-14-inhaler-recall-subpotent-salmeterol-risk. Based on FDA recall #D-0023-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0023-2022%22&limit=1).
Why it’s dangerous
The inhaler may contain less salmeterol than labeled, which is a long-acting bronchodilator for asthma. This could lead to less effective asthma control if the inhaler isn't delivering the full dose of medication.
Who’s affected
People with asthma prescriptions for this specific inhaler are affected. Those who use the inhaler regularly for asthma control are most at risk.
How to tell if you have this one
Check for the NDC code 59310-111-06 on the packaging. The inhaler was manufactured in Ireland and sold by Teva Respiratory, LLC in Frazer, PA.
- Brand
Teva- Category
Drug
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
USA Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0021-2022 | AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC , Frazer, PA 19355, Manufactured in Ireland, NDC 59310-520-08; AFR17A | 10,665 inhalers |
| D-0022-2022 | AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-530-08.; AFR18A | 3,240 inhalers |
| D-0023-2022 | AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA 19355, Manufactured in Ireland, NDC 59310-111-06; AFR16A | 1,978 inhalers |
| D-0024-2022 | AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-129-06.; AFR17A | 4,850 inhalers |
| D-0025-2022 | AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-136-06; AFR18A | 5,500 inhalers |
What to do — step by step
Check Product Details
Look for the NDC code 59310-111-06 on the inhaler packaging to confirm it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 17 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.
Questions people ask
Is this inhaler safe to use?
The recall states there may be less salmeterol than labeled, which could reduce effectiveness. Teva recommends checking the NDC code to confirm if it's affected.
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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-0023-2022 (September 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0023-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.