Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule Recalled by Medtech Products, Inc. Due to Marketed without an approved NDA/ANDA: The distributed units...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtech Products, Inc. directly.
Affected Products
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
Quantity: 4,175 cases (50,100 ovules); and 6 cases (72 ovules) as company samples
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtech Products, Inc.
Medtech Products, Inc. has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report