The Recall Desk
ModerateFDA (Drugs)·D-0024-2022·Announced 2021-10-27

AirDuo Digihaler inhalation powder subpotent drug recall

Teva Pharmaceuticals is recalling AirDuo Digihaler 113/14 inhalation powder because some batches do not deliver the labeled amount of salmeterol, a critical active ingredient for asthma and COPD control.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall of a subpotent drug. The source text does not report any illnesses or injuries, and the hazard is one of potential underdosing rather than contamination or direct harm. The recall is precautionary in nature—patients are at risk of inadequate disease control, but no adverse events are documented in the source material.

Plain-English summary

Teva Pharmaceuticals USA is recalling AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder nationwide. The product is a prescription medication used to treat asthma and chronic obstructive pulmonary disease (COPD).

The recall was initiated because testing revealed that some inhalers do not emit the label-claimed dose of salmeterol, one of the two active ingredients in this combination product. This means patients using affected units may receive less medication than prescribed, potentially compromising disease control.

The recalled product was manufactured in Ireland and marketed by Teva Respiratory, LLC (Frazer, PA). Affected inhalers carry NDC 59310-129-06 and lot code AFR17A. Approximately 4,850 inhalers were distributed nationwide.

Patients currently using AirDuo Digihaler should contact their prescriber or pharmacist to determine whether their inhaler is affected and to discuss whether they should switch to an alternative medication while the issue is being resolved.

The recalled product

Product
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.
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Inhalation / Respiratory
Hazard
  • subpotent
  • underdose

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • AFR17A

Distribution

Distributed nationwide across the United States.

Related recalls

Same category