CLASS II Drug recall · Reported 14 Apr 2021 · FDA Enforcement Report
Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) recalled
Cosette Pharmaceuticals is recalling Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) (, distributed nationwide in the US. The recall was initiated on 25 Mar 2021 and the FDA has classified it as Class II.
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-0327-2021
- FDA event ID
- 87608
- Recalling firm
- Cosette Pharmaceuticals, South Plainfield, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Mar 2021
- FDA classified
- 7 Apr 2021
- Reported
- 14 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 25 Mar 2021 | Recall initiated by company | |
| 7 Apr 2021 | Classified by FDA | +13 days |
| 14 Apr 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviaitons
Product as listed by the FDA
Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53), Rx Only, Distributed by: Cosette Pharmaceuticals, Inc., South Plainfield, NJ 07080
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
CGMP Deviaitons
Which lots are affected?
a) 30 mL: 1014611 and 1014612, exp 12/2022 b) 60 mL:1014593, 1014594 and 1014595, exp 10/2022
Where was it sold?
Nationwide in the US
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other Mometasone Furoate recalls
All 9| 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 | Sinuva (mometasone furoate) sinus implant, 1350 mcg, 1 implant recalledSinuva | Intersect ENT | Potency & Assay | Nationwide |
| Drug | CLASS III | Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a)-bottle recalledMometasone Furoate | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |