MONISTAT 1 SIMPLE CURE — Class III drug recall D-1077-2015
Terminated recall by Medtech Products, Inc., reported 2015-05-20, distributed nationwide. Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include only the 1200 m
| Recall number | D-1077-2015 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtech Products, Inc., Tarrytown, NY, United States |
| Recall initiated | 2015-04-10 |
| Classified | 2015-05-13 |
| Reported by FDA | 2015-05-20 |
| Terminated | 2016-03-03 |
| Distributed | Nationwide (US) |
| Reason classes | unapproved product |
| NDC | 63736-0013, 63736-0013-30 |
| Lot numbers | R18193 |
| Expiration dates | 2016-10 |
Product
MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-DAY MAXIMUM STRENGTH TREATMENT OVULE per case, over-the-counter, Distributed by INSIGHT Pharmaceuticals, LLC, Trevose, PA 19053-8433, NDC 63736-013-30
Reason for recall
Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include only the 1200 mg vaginal suppository; the approved NDA requires both a 1200 mg vaginal suppository and the 2% topical cream.
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-1077-2015. 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.