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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

Mylan Pharmaceuticals Inc.: Dymista Nasal Spray Recalled Due to Potential Glass Fragments

Agency Publication Date: August 9, 2018
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Summary

Mylan Pharmaceuticals is voluntarily recalling 20,780 bottles of Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray. The recall was initiated because of the potential presence of foreign substance glass fragments in the neck area of the glass bottles. This prescription-only medication is used for treating allergy symptoms, and approximately 20,780 bottles are included in this nationwide recall.

Risk

If glass fragments are present in the bottle, there is a risk that they could be inhaled or cause physical injury to the nasal passage during use. No specific injuries have been reported in the available data, but the presence of foreign glass in a nasal spray poses a mechanical safety hazard.

What You Should Do

  1. Immediately check your Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray (137 mcg / 50 mcg per spray) for the following lot numbers and expiration dates: Lot GA70246 or Lot GA70254, both with an expiration date of 02/2019.
  2. If your bottle matches the affected lot numbers, stop using the medication immediately.
  3. Contact your healthcare provider or pharmacist to discuss your treatment options and to obtain a replacement prescription if necessary.
  4. Return any unused portions of the affected medication to the pharmacy where it was purchased for a refund.
  5. Contact Mylan Pharmaceuticals Inc. at their headquarters in Morgantown, WV, or via their distributor for further instructions regarding this recall.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return to pharmacy.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray (23 g)
Model:
NDC 0037-0245-23
Recall #: D-1075-2018
Lot Numbers:
GA70246 (Exp 02/2019)
GA70254 (Exp 02/2019)
Date Ranges: Expiration 02/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 77850
Status: Resolved
Manufacturer: Mylan Pharmaceuticals Inc.
Sold By: pharmacies; healthcare providers
Manufactured In: India, United States
Units Affected: 20,780 bottles
Distributed To: Nationwide

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.