Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray) Recalled by Sun Pharmaceutical Industries, Inc. Due to Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sun Pharmaceutical Industries, Inc. directly.
Affected Products
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
Quantity: 17554 bottles
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sun Pharmaceutical Industries, Inc.
Sun Pharmaceutical Industries, Inc. has 40 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report