Padagis recalls Gynazole-1 vaginal cream due to incorrect silica formulation. This may cause irritation or other issues. Contact for return instructions.
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Take action
Contact the company
📍Recalling firmPadagis US LLC3940 Quebec Ave N · Minneapolis, MN 55427-1244
“Padagis Gynazole-1 Vaginal Cream Recall: Incorrect Silica Formulation.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33092-padagis-gynazole-1-vaginal-cream-recall-incorrect-silica-formulation. Based on FDA recall #D-0081-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0081-2024%22&limit=1).
Padagis US LLC, acting voluntarily, recalled Gynazole-1 vaginal cream nationwide on Sept. 28, 2023, after the FDA announced the product was manufactured with incorrect silica formulation. The recall affects 10,512 cartons distributed across the United States.
How to tell if you have it
Brand: Padagis
Product: Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator
NDC: 45802-396-01
Lot#: 164185
Exp. Date: 4/2024
The hazard
The product was manufactured using Hydrophilic Colloidal Silica instead of the required Hydrophobic Colloidal Silica, according to the FDA recall record.
Context
GovInfoNow's records show Padagis US LLC has conducted seven other recalls since Dec. 27, 2021, including a June 23, 2026, Nystatin Cream recall for subpotent drug risk and a Feb. 6, 2025, Estradiol Gel recall involving defective containers. Other recent recalls of similar products include a Medline Silicone Cream recall (June 11, 2026) for formaldehyde risk and a Sun Pharmaceutical Diclofenac Gel recall (Jan. 27, 2026) for failed viscosity specifications.
How to tell if you have this one
Check for the product name 'Gynazole-1', 2% butoconazole nitrate vaginal cream, 5.8g per pre-filled applicator, packaged in 1 per carton. The lot number is 164185 with an expiration date of April 2024.
Brand
Padagis
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the product name 'Gynazole-1', 2% butoconazole nitrate vaginal cream, 5.8g per pre-filled applicator, packaged in 1 per carton.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0081-2024 (September 28, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0081-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.