Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
SINUVA (mometasone furoate) sinus implant Recalled by Intersect ENT, Inc. Due to Failed Dissolution Specification; product did not meet the...
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 Intersect ENT, Inc. directly.
Affected Products
SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menlo Park, CA 94025, NDC 10599-003-01.
Quantity: 9898 pouches
Why Was This Recalled?
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Intersect ENT, Inc.
Intersect ENT, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report