CLASS III Drug recall · Reported 25 Jan 2023 · FDA Enforcement Report
Sinuva (mometasone furoate) sinus implant, 1350 mcg, 1 implant recalled
Intersect ENT is recalling Sinuva (mometasone furoate) sinus implant, 1350 mcg, 1 implant per, distributed nationwide in the US. The recall was initiated on 4 Jan 2023 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-0167-2023
- FDA event ID
- 91348
- Recalling firm
- Intersect ENT, Menlo Park, CA
- Brand
- Sinuva
- Manufacturer
- Intersect ENT, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 Jan 2023
- FDA classified
- 19 Jan 2023
- Reported
- 25 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 4 Jan 2023 | Recall initiated by company | |
| 19 Jan 2023 | Classified by FDA | +15 days |
| 25 Jan 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
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
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.
Where it was distributed
Nationwide
Questions about this recall
Is Sinuva (mometasone furoate) sinus implant, 1350 mcg, 1 implant per recalled?
Yes. Intersect ENT recalled Sinuva (mometasone furoate) sinus implant, 1350 mcg, 1 implant per on 4 Jan 2023. The recall is Class III and its status is Terminated. Recall number D-0167-2023.
Why was it recalled?
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
Which lots are affected?
Lot #s: 10111003, Exp 12/31/2022; 10203002, Exp 01/31/2023; 10302002, 10325001, Exp 02/28/2023; 10519001, 10526002, Exp 04/30/2023; 10602002, Exp 05/31/2023; 10819004, Exp 09/30/2023; 21092101, 21111901, Exp 10/31/2023; 21110402, Exp 12/31/2023.
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 21 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 Intersect ENT
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Propel Mini Mometasone Furoate Sinus Implant recalled by Intersect ENT | Intersect ENT | Packaging Defects | Nationwide |
Other Mometasone Furoate recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Asmanex Twisthaler, mometasone furoate inhalation powder recalledAsmanex | Organon | Other | Nationwide |
| Drug | CLASS III | Asmanex Twisthaler, mometasone furoate inhalation powder recalledAsmanex | Organon | Other | Nationwide |
| Drug | CLASS II | Asmanex Twisthaler (mometasone furoate inhalation powder recalledAsmanex | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a)-bottle recalledMometasone Furoate | Glenmark Pharmaceuticals Inc., U | Other | Nationwide |
| Drug | CLASS II | Mometasone Furoate Cream recalled by Glenmark PharmaceuticalsMometasone Furoate | Glenmark Pharmaceuticals Inc., U | Packaging Defects | Nationwide |