CLASS II Device recall · Reported 6 Mar 2013 · FDA Enforcement Report

KY SilkE Vaginal Moisturizer and Personal Lubricant recalled

Mc-Neil-ppc is recalling KY SilkE Vaginal Moisturizer and Personal Lubricant, distributed nationwide in the US. The recall was initiated on 25 Jan 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCarton: 380040087149 Case Code: 008714 V05 Outer case UPC Code: 103800400871460055 Outer case Display UPC Code: 00380041153300

Quantity recalled750,264 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0874-2013
FDA event ID: 64322
Recalling firm: Mc-Neil-ppc, Skillman, NJ
Classification: Class II
Status: Terminated
Recall initiated: 25 Jan 2013
FDA classified: 22 Feb 2013
Reported: 6 Mar 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

25 Jan 2013	Recall initiated by company
22 Feb 2013	Classified by FDA	+28 days
6 Mar 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

This product is not cleared for marketing in the US.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

This product is not cleared for marketing in the US.

Which lots are affected?

Carton: 380040087149 Case Code: 008714 V05 Outer case UPC Code: 103800400871460055 Outer case Display UPC Code: 00380041153300

Where was it sold?

Nationwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 64322

This product is part of a recall event; the main page for the event is KY Sensitive TM Jelly Personal Lubricant recalled by Mc-NEIL-PPC.

Reported	Class	Recall	Company	Reason	Where
6 Mar 2013	CLASS II	KY Sensitive TM Jelly Personal Lubricant recalled by Mc-NEIL-PPC	Mc-Neil-ppc	Packaging Defects	Nationwide
6 Mar 2013	CLASS II	KY Tingling Jelly Personal Lubricant recalled by Mc-NEIL-PPC	Mc-Neil-ppc	Packaging Defects	Nationwide

More recalls from Mc-Neil-ppc

All 4

Reported	Class	Recall	Company	Reason	Where
6 Mar 2013Device	CLASS II	KY Tingling Jelly Personal Lubricant recalled by Mc-NEIL-PPC	Mc-Neil-ppc	Packaging Defects	Nationwide
6 Mar 2013Device	CLASS II	KY Sensitive TM Jelly Personal Lubricant recalled by Mc-NEIL-PPC	Mc-Neil-ppc	Packaging Defects	Nationwide
3 Oct 2012Device	CLASS II	KY Liquibeads Vaginal Moisturizer recalled by Mc-NEIL-PPC	Mc-Neil-ppc	Other	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide