CLASS II ONGOING Drug recall · Reported 8 Nov 2023 · FDA Enforcement Report
Gynazole-1, (Butoconazole Nitrate) Vaginal Cream recalled by Padagis US
Padagis US is recalling Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, distributed nationwide in the US. The recall was initiated on 28 Sep 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0081-2024
- FDA event ID
- 93189
- Recalling firm
- Padagis US, Minneapolis, MN
- Brand
- Gynazole 1
- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Sep 2023
- FDA classified
- 31 Oct 2023
- Reported
- 8 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Creams, Ointments & Gels
Timeline
| 28 Sep 2023 | Recall initiated by company | |
| 31 Oct 2023 | Classified by FDA | +33 days |
| 8 Nov 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per carton, Rx Only, Manufactured By Padagis, Yeruham, Israel; Distributed By: Padagis, Allegan, MI 49010. NDC: 45802-396-01
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Which lots are affected?
Lot#: 164185, Exp. Date 4/2024
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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