KY Sensitive Jelly Personal Lubricant Recalled for Lack of FDA Clearance
McNeil-PPC Inc. is recalling KY Sensitive Jelly Personal Lubricant 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, which typically corresponds to a moderate severity level where the product may cause temporary or medically reversible adverse health consequences, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
McNeil-PPC Inc. is recalling 1,185,664 units of KY Sensitive Jelly Personal Lubricant. The product is packaged in 3 oz tubes and distributed nationwide. The recall is being conducted because the product is not cleared for marketing in the US.
The recall involves specific tube and case codes, including Tube UPC 380040085503 and Case Codes 008550 V21 and 008550 V00. Consumers should check their products for these codes. The source text does not specify a particular date range or additional distribution details beyond nationwide distribution.
Consumers are advised to stop using the product and contact the recalling firm for further instructions. The FDA has classified this as a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.
- Manufacturer
- Mc-NEIL-PPC, Inc.
- Affected units
- 1,185,664
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 (1)
- Tube UPC: 380040085503 Case Code(s): 008550 V21
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.
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