KY SilkE Vaginal Moisturizer Recalled for Lack of FDA Clearance
McNeil-PPC is recalling KY SilkE Vaginal Moisturizer because the product is not cleared for marketing in the US.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is regulatory (lack of clearance) rather than a specific physical or chemical defect with reported injuries, fitting the criteria for a moderate severity voluntary or regulatory recall.
Plain-English summary
McNeil-PPC, Inc. is recalling KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles and distributed nationwide. The recall involves 750,264 units.
The recall was initiated because the product is not cleared for marketing in the United States. The source text does not report any specific illnesses, injuries, or adverse health consequences associated with the use of this product.
Consumers who have this product should stop using it and contact the recalling firm for further instructions. The recall number is Z-0874-2013.
The recalled product
- Product
- KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.
- Manufacturer
- Mc-NEIL-PPC, Inc.
- Affected units
- 750,264
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Mc-NEIL-PPC, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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