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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

AirDuo Digihaler Inhalers Recalled for Subpotency Concerns

Agency Publication Date: October 21, 2021
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Summary

Teva Pharmaceuticals USA has recalled 26,233 units of AirDuo Digihaler (fluticasone propionate and salmeterol) Inhalation Powder due to concerns that the devices are subpotent. Testing revealed that the delivered dose of salmeterol was below the required levels specified on the label. The recall includes various strengths of both prescription and sample inhalers distributed to pharmacies and healthcare providers nationwide.

Risk

A subpotent inhaler may not deliver the full amount of medication required to manage asthma symptoms. If a patient receives a lower dose of salmeterol than intended, they may experience a worsening of their condition or inadequate relief during respiratory distress. No injuries or incidents have been reported in connection with this issue.

What You Should Do

  1. The recalled products are AirDuo Digihaler (fluticasone propionate and salmeterol) Inhalation Powder inhalers in 55/14 mcg, 113/14 mcg, and 232/14 mcg strengths.
  2. Identify your product by checking for National Drug Codes (NDC) 59310-520-08, 59310-530-08, 59310-111-06, 59310-129-06, or 59310-136-06 and lot numbers AFR16A, AFR17A, or AFR18A.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: AirDuo Digihaler 113/14 Inhalation Powder
Variants: 113 mcg fluticasone propionate, 14 mcg salmeterol, Sample Not For Sale
Model:
D-0021-2022
Lot Numbers:
AFR17A
NDC:
59310-520-08

Quantity: 10,665 inhalers

Product: AirDuo Digihaler 232/14 Inhalation Powder
Variants: 232 mcg fluticasone propionate, 14 mcg salmeterol, Sample Not For Sale
Model:
D-0022-2022
Lot Numbers:
AFR18A
NDC:
59310-530-08

Quantity: 3,240 inhalers

Product: AirDuo Digihaler 55/14 Inhalation Powder
Variants: 55 mcg fluticasone propionate, 14 mcg salmeterol, Rx Only
Model:
D-0023-2022
Lot Numbers:
AFR16A
NDC:
59310-111-06

Quantity: 1,978 inhalers

Product: AirDuo Digihaler 113/14 Inhalation Powder
Variants: 113 mcg fluticasone propionate, 14 mcg salmeterol, Rx Only
Model:
D-0024-2022
Lot Numbers:
AFR17A
NDC:
59310-129-06

Quantity: 4,850 inhalers

Product: AirDuo Digihaler 232/14 Inhalation Powder
Variants: 232 mcg fluticasone propionate, 14 mcg salmeterol, Rx Only
Model:
D-0025-2022
Lot Numbers:
AFR18A
NDC:
59310-136-06

Quantity: 5,500 inhalers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88738
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA
Sold By: Pharmacies; Healthcare Providers
Manufactured In: Ireland, United States
Units Affected: 5 products (10,665 inhalers; 3,240 inhalers; 1,978 inhalers; 4,850 inhalers; 5,500 inhalers)
Distributed To: Nationwide
Agency Last Updated: July 15, 2022

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.