Agency classClass IOur severity:Critical FDA (Drugs)·D-338-2013·Announced 2013-05-22

Casanova Capsules Recalled for Undeclared Sildenafil and Tadalafil

Performance Plus Marketing is recalling Casanova Capsules because they may contain undeclared sildenafil and tadalafil, making them unapproved drugs.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA has classified this recall as Class I, which corresponds to a Critical severity score of 5 according to the rubric.

Plain-English summary

Performance Plus Marketing, Inc. is recalling Casanova Capsules, 450 mg, Male Sexual Enhancer. The product is supplied in 1-count blister packs with UPC 736211906892 and was distributed nationwide by Casanova Distributors in Tucker, GA. The recall involves 96,000 capsules from Lot# 030112, which has an expiration date of 03/15.

The FDA has classified this as a Class I recall because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The capsules may contain undeclared sildenafil, tadalafil, and analogues of these FDA-approved active ingredients. Consequently, the product is considered an unapproved drug.

Consumers who have purchased this product should stop using it immediately. They should contact the recalling firm or their healthcare provider for further instructions on how to dispose of the medication safely.

The recalled product

Product: CASANOVA Capsules, 450 mg, MALE SEXUAL ENHANCER, supplied i n1 count blister packs, UPC 736211906892; Distributed by: Casanova Distributors, Tucker, GA
Manufacturer: Performance Plus Marketing, Inc.
Category: Drug — Sexual Enhancer
Hazard: undeclared-ingredients
unapproved-drug
Affected units: 96,000

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# 030112
Exp: 03/15

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Performance Plus Marketing, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · Performance Plus Marketing, Inc.

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Same hazard · undeclared ingredients