Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Mar 25, 2021 (6 years ago)

Mometasone Furoate Topical Solution

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviaitons

Cause type: cGMP deviation

Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.

What was recalled

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

Affected NDCs 0713-0701-53 0713-0701-85

Compare with the code on your package — it is the most precise check available.

Drug: Mometasone

Recalling firm
Cosette Pharmaceuticals, Inc.
NDC code
0713-0701-85
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0327-2021 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Mometasone recalls

See all
Class III · Low risk

SINUVA (mometasone furoate)

Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.

Terminated Dissolution failure Intersect ENT, Inc. NDC 10599-003-01 D-0167-2023

Other cgmp deviation recalls from 2021

All cgmp deviation recalls