K-Y Liquibeads Vaginal Moisturizer Recalled for Regulatory Compliance
Johnson & Johnson is voluntarily recalling K-Y Liquibeads Vaginal Moisturizer to address FDA concerns regarding the product's medical device clearance status.
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 a voluntary precautionary action taken to address regulatory clearance issues, with the source explicitly stating it is not based on consumer safety or product performance issues.
Plain-English summary
Johnson & Johnson Healthcare Products (JJHP) is voluntarily recalling K-Y Liquibeads Vaginal Moisturizer to address FDA concerns that the product should have been cleared under a separate medical device application. The recall involves 818,712 units distributed nationwide. Specific lot numbers identified in the recall include 2721W, 2591W, 2321W, 1681W, 0921W, 0651W, 0471W, 0361W, 0221W, 0041W, 0110H, 0100H, 0090H, 0080H, 0030H, 0179H, 0159H, 0219H, and 3489RT.
The source text explicitly states that this voluntary recall is not being conducted on the basis of any consumer safety or product performance issues related to K-Y Liquibeads. Instead, the action follows a Warning Letter received by JJHP on May 23, 2012, indicating regulatory concerns about the product's classification and clearance requirements.
Consumers with this product are advised to check their lot numbers against the list provided. Since the recall is driven by regulatory compliance rather than reported safety hazards, no specific consumer safety instructions beyond verifying the product status are detailed in the source text.
The recalled product
- Product
- KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant
- Manufacturer
- Mc-NEIL-PPC, Inc.
- Affected units
- 818,712
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- The following Lot Numbers were identified: 2721W
- 2591W
- 2321W
- 1681W
- 0921W
- 0651W
- 0471W
- 0361W
- 0221W
- 0041W
- 0110H
- 0100H
- 0090H
- 0080H
- 0030H
- 0179H
- 0159H
- 0219H and 3489RT.
Distribution
Distributed nationwide across the United States.
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