Severity
Moderate
ModerateClass IIOngoing
FDA Drug recall · Reported November 8, 2023
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
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Padagis US LLC recalled Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled app… - a moderate-severity action.
Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled app… was recalled by Padagis US LLC in November 8, 2023. Reason: Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than H…. Check the official notice for the remedy. Verify recall #D-0081-2024 with the FDA Drug before acting.
The recall
Padagis US LLC issued this moderate-severity FDA Drug recall-Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than H….
- Moderate
- severity level
- Class II
- classification
- November 8, 2023
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0081-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0081-2024) was formally reported on November 8, 2023, with the manufacturer initiating the action on September 28, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Padagis US LLC is listed as the recalling firm, operating out of Minneapolis, MN. Federal records list the affected scope as 10,512 cartons.
The documented reason for this recall is: Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process. Distribution data in the federal record shows the product reached: Nationwide within the United States. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Cosmetics & Personal Care recalls over time
Where this recall sits in its category - 1,360 cosmetics & personal care recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
10,512 cartons
Related Recalls
6
3 from same agency
Product description
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
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0081-2024 |
| Date reported | November 8, 2023 |
| Date initiated | September 28, 2023 |
| Recalling firm | Padagis US LLC |
| Firm location | Minneapolis, MN |
| Affected scope | 10,512 cartons |
| Distribution | Nationwide within the United States |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0081-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Padagis US LLC. Units affected: 10,512 cartons.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Drug on November 8, 2023. Severity: Moderate. Recall number: D-0081-2024.
Where was the recalled product distributed? ▼
Distribution: Nationwide within the United States.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0081-2024) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
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· 2026-06-04
FDA Food Critical
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PS Seasoning & Spices, Inc. · 2026-05-27
FDA Food Critical
VG7274D1 Natural Cream of Mushroom Type Flavor, Net Weight: 50 lbs. bag. Item #: R5302. For Further Processing. …
Fontana Flavors, Inc · 2026-05-27
FDA Drug Critical
MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Pha…
Wisconsin Pharmacal Company · 2026-05-27
FDA Drug Moderate
Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1…
SUN PHARMACEUTICAL INDUSTRIES INC · 2026-04-22
Compare this recall with Tiny Land Children's Play Tents Recalled Due to Risk of Inj… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported November 8, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.