Glenmark Mometasone Furoate Cream — Class II drug recall D-0336-2018
Terminated recall by Glenmark Pharmaceuticals Inc., USA, reported 2018-02-07, distributed nationwide. CGMP Deviations: Market complaints related to "gritty texture".
| Recall number | D-0336-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2017-11-20 |
| Classified | 2018-02-07 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2018-10-03 |
| Distributed | Nationwide (US) |
| Quantity | 5,136 tubes |
| Reason classes | cgmp |
| UPC / GTIN / UDI-DI | 03684620192559 |
| Lot numbers | 03/19, 05170598 |
Product
Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 NDC 68462019255 UPC 3684620192559
Reason for recall
CGMP Deviations: Market complaints related to "gritty texture".
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0336-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.