Mometasone Furoate Cream USP — Class II drug recall D-1586-2019
Terminated recall by Glenmark Pharmaceuticals Inc., USA, reported 2019-08-14, distributed nationwide. GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.
| Recall number | D-1586-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2019-07-23 |
| Classified | 2019-08-02 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2021-10-26 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| NDC | 68462-0192, 68462-0192-17, 68462-0192-55 |
| Expiration dates | 2019-08-20, 2019-09-20, 2019-12-20, 2020-01-20, 2020-02-20, 2020-04-20, 2020-05-20, 2020-06-20, 2020-07-20, 2020-08-20 |
Product
Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 68462-192-55), Rx Only, Manufactured by; Glenmark Pharmaceuticals Ltd At: Village: Kishanpura, Baddi Nalagari Road, District: Solan, Himachal Pradesh -173205, India Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Reason for recall
GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.
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-1586-2019. 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.