FDA Drug recall D-0336-2018
Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark Pharmaceuticals Ltd
- FDA Drug
- Class II
- terminated
- Published 2018-02-07
On 2018-02-07 the FDA classified a Class II recall of Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark Pharmaceuticals Ltd by Glenmark Pharmaceuticals Usa, citing CGMP Deviations: Market complaints related to "gritty texture".
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0336-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-20 |
| Published | 2018-02-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
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
CGMP Deviations: Market complaints related to "gritty texture".
Identifiers
| upc | 3684620192559 |
|---|---|
| code_info | Batch Number: 05170598; Exp. 03/19 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0336-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.