Z-2467-2012Class II

KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC...

Name: Z-2467-2012 KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC...
Creator: Mc-NEIL-PPC, Inc.
Published: 2012-07-02
License: https://open.fda.gov/license/

Kenvue Brands LLC / initiated 2012-07-02 / Terminated

FDA source

Mc-NEIL-PPC, Inc. began a recall of KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant on 2012-07-02. FDA classified it as Class II and gives the reason as "Johnson & Johnson Healthcare Products (JJHP) is voluntarily recalling this product to address FDA concerns that the product should have been cleared under a separate medical device application. This voluntary recall is...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2467-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-02
Posted: 2012-09-27
Terminated: 2013-09-27
Recalling firm: Kenvue Brands LLC
Product: KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant
Product code: NUC Lubricant, Personal
Reason for recall: Johnson & Johnson Healthcare Products (JJHP) is voluntarily recalling this product to address FDA concerns that the product should have been cleared under a separate medical device application. This voluntary recall is not being conducted on the basis of any consumer safety or product performance issues related to K-Y LIQUIBEADS. JJHP received a Warning Letter on May 23, 2012 indicating that thi
FDA root cause: No Marketing Application
Action: Johnson & Johnson sent Recall Letters/Response forms dated June 29, 2012 on July 2, 2012. The recall notification included affected lots and instructions for wholesale distributors and retailers that handle the product. The recalled product is being handled by Stericycle. The notification included phone and fax numbers in the event assistance is required. Customers were asked to complete the enclosed business Reply Form and return immediately; identify all warehouse/wholesale inventories of products and return immediately per the attached "Return Authorization Form." For any questions regarding the form, customers were asked to call Stericycle at 888-406-9309. Customers could also fax questions to 877-877-0318. Once customers have collected all returns, they should send back immediately per the enclosed instructions. For questions regarding this recall call 908-874-1000.
Quantity in commerce: 818,712
Distribution: Nationwide Distribution
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2467-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2467-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-27

Product code NUC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)