CLASS III Drug recall · Reported 13 Jul 2022 · FDA Enforcement Report
Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a)-bottle recalled
Glenmark Pharmaceuticals Inc., USA is recalling Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a)-bottle (, distributed nationwide in the US. The recall was initiated on 16 Jun 2022 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-1173-2022
- FDA event ID
- 90473
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Brand
- Mometasone Furoate
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 16 Jun 2022
- FDA classified
- 1 Jul 2022
- Reported
- 13 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Creams, Ointments & Gels
Timeline
| 16 Jun 2022 | Recall initiated by company | |
| 1 Jul 2022 | Classified by FDA | +15 days |
| 13 Jul 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container
Product as listed by the FDA
Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC 68462-385-02), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Baddi Himachal Pradesh 173205, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah NJ 07430.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Defective Container
Which lots are affected?
Lot # a) 05201358, Exp 06/2022; 05210287, 05210288, Exp 01/2023; 05211446, Exp 07/2023; 05211704, 05211714, Exp 08/2023; 05212217, Exp 10/2023: b) 05201358, Exp 06/2022; 05210287, 05210288, 05210424, Exp 01/2023; 05210425, 05210435, Exp 02/2023; 05211427, 05211439, 05211445, Exp 07/2023; 05211723, 05211731, 05211850, 05211864, Exp 08/2023; 05212226, 05212250, 05212261, Exp 10/2023.
Where was it sold?
Nationwide in the USA
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 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.
More recalls from Glenmark Pharmaceuticals Inc., USA
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|---|---|---|---|---|---|
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| Drug | CLASS III | Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |
| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalled | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
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 II | Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) recalled | Cosette Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |