Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy

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.

© 2026 Go Backs. All rights reserved.

Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Mylan Pharmaceuticals Inc.: Dymista Nasal Spray Recalled Due to Potential Broken Glass in Bottle Neck

Agency Publication Date: February 4, 2019
Share:
Sign in to monitor this recall

Summary

Mylan Pharmaceuticals Inc. has recalled 10,390 bottles of Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray because the glass bottles may be defective. There is a potential for broken glass to be present in the neck area of the 23-gram bottles. This prescription medication, used for seasonal allergies, was distributed nationwide across the United States. Consumers should immediately check their prescription bottles to see if they are part of the affected lot and contact their healthcare provider for guidance on continuing treatment.

Risk

The presence of broken glass in the neck of the bottle could lead to glass fragments being discharged during use or causing injury to the user's hands or nasal passages during administration.

What You Should Do

  1. Identify if you have the affected product by checking the label for Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, in a 23 g net fill weight bottle.
  2. Check the bottle and packaging for Lot: GA70535 with an expiration date of April 2019.
  3. Contact your healthcare provider or pharmacist immediately for guidance if you are using this medication and have a bottle from the affected lot.
  4. Return any unused product from the affected lot to your pharmacy for a refund and to ensure it is properly handled.
  5. Contact Mylan Pharmaceuticals Inc. at their headquarters or through your dispensing pharmacy for further instructions regarding the defective containers.
  6. For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Healthcare provider consultation and pharmacy refund.

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
M.L. No. 546
Lot Numbers:
GA70535 (Exp. April 2019)
Date Ranges: April 2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81980
Status: Resolved
Manufacturer: Mylan Pharmaceuticals Inc.
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: 10,390 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 · 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.