Mometasone Furoate Topical Solution (Glenmark) - Defective Container (2022)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Glenmark Pharmaceuticals Inc., USA
Lot Codes / Batch Numbers
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.
Products Sold
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.
Glenmark Pharmaceuticals Inc., USA is recalling Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml due to Defective Container. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Defective Container
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026