FDA Recalls Pink Pussycat Sensual Enhancement Capsules for Undeclared Sildenafil
Pink Pussycat Sensual Enhancement capsules are being recalled nationwide. The FDA found they contain undeclared sildenafil and were marketed without FDA approval.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as FDA Class I, which by rule establishes a minimum severity score of 4. The product contains an undeclared pharmaceutical ingredient and was marketed without required FDA approval.
Plain-English summary
Pink Pussycat Sensual Enhancement capsules (3000mg, 1-count blister cards) manufactured for Pink Pussycat Products in Chatsworth, California are being recalled. The product was distributed nationwide in the USA through walmart.com. The recall affects Lot 2009066 with an expiration date of 09/2023.
The FDA determined that this product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analysis found the product contains undeclared sildenafil, an active ingredient found in FDA-approved products for male sexual enhancement treatment. Because the product lacks required FDA approval and contains an undeclared pharmaceutical ingredient, it is considered an unapproved drug.
The recalled product
- Product
- Pink Pussycat SENSUAL ENHANCEMENT capsule, 3000mg, 1-count blister card, Manufactured for: Pink Pussycat Products - Chatsworth, CA 91311, UPC 8 91875 00462 6.
- Manufacturer
- Pink Toyz
- Affected units
- 120
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 (2)
- Lot: 2009066
- Exp: 09/2023
Distribution
Distributed nationwide across the United States.
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