CLASS II Drug recall · Reported 13 Feb 2019 · FDA Enforcement Report
Dymista (azelastine hydrochloride recalled by Mylan Pharmaceuticals
Mylan Pharmaceuticals is recalling Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg, distributed nationwide in the US. The recall was initiated on 1 Feb 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0424-2019
- FDA event ID
- 81980
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Brand
- Dymista
- Manufacturer
- Viatris Specialty LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Feb 2019
- FDA classified
- 4 Feb 2019
- Reported
- 13 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Nasal Sprays
Timeline
| 1 Feb 2019 | Recall initiated by company | |
| 4 Feb 2019 | Classified by FDA | +3 days |
| 13 Feb 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container: Potential for broken glass in the neck area of the glass bottles.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120 Metered Sprays, 23 g net fill weight bottle, Rx Only, Manufactured by: Cipla Ltd., Goa, India, M.L. No. 546; For: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120, NDC 0037-0245-23.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Defective Container: Potential for broken glass in the neck area of the glass bottles.
Which lots are affected?
Lot: GA70535, Exp. April 2019
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Acamprosate Calcium, Delayed-Release Tablets, 333 mg recalledAcamprosate Calcium | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
Other Azelastine recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azelastine HCl Ophthalmic Solution recalled by ApotexAzelastine Hydrochloride | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS III | Azelastine HCl Ophthalmic Solution 0.05% in HDPE bottle recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Dymista (azelastine hydrochloride recalled by Mylan PharmaceuticalsDymista | Mylan Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS III | Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray) recalledAzelastine Hydrochloride | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |