CLASS III Drug recall · Reported 21 Feb 2018 · FDA Enforcement Report
Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray) recalled
Sun Pharmaceutical Industries is recalling Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), distributed nationwide in the US. The recall was initiated on 5 Feb 2018 and the FDA has classified it as Class III.
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-0417-2018
- FDA event ID
- 79145
- Recalling firm
- Sun Pharmaceutical Industries, Cranbury, NJ
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Feb 2018
- FDA classified
- 13 Feb 2018
- Reported
- 21 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Nasal Sprays
Timeline
| 5 Feb 2018 | Recall initiated by company | |
| 13 Feb 2018 | Classified by FDA | +8 days |
| 21 Feb 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, Rx only, Distributed by: Sun Pharmaceutical Ind. Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Halol - 389 350, Gujarat, India --- NDC 47335-779-91
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station
Which lots are affected?
JKR7706A December 2018 JKR7705A November 2018
Where was it sold?
Nationwide
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Sun Pharmaceutical Industries
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|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Perampanel CIII Tablets, 6mg recalled by Sun Pharmaceutical IndustriesPerampanel | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |
| Drug | CLASS I | DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
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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 II | Dymista (azelastine hydrochloride recalled by Mylan PharmaceuticalsDymista | Mylan Pharmaceuticals | Foreign Material | 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 |