Sun Pharmaceutical Recalls Azelastine HCl Nasal Spray for Stability Test Failure
Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution 0.1% because it failed a droplet size stability test. The recall covers 17,554 bottles distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The issue is a technical stability test failure regarding droplet size, not a direct safety hazard like contamination or mislabeling.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle), prescription only. The recall was initiated following a failure to meet the % RSD requirement in the test for Droplet Size during the 6-month long-term stability test station.
The affected product is identified by NDC 47335-779-91. The recall includes 17,554 bottles with lot codes JKR7706A (December 2018) and JKR7705A (November 2018). The product was distributed nationwide.
Consumers should check their nasal spray bottles for the specific NDC and lot codes listed above. If the product matches the recalled items, they should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- AZELASTINE HYDROCHLORIDE (AZELASTINE HYDROCHLORIDE)
- Brand
- AZELASTINE HYDROCHLORIDE
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Category
- Drug — Nasal Spray
- Hazard
- Affected units
- 17,554
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- JKR7706A December 2018 JKR7705A November 2018
Distribution
Distributed nationwide across the United States.
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