Agency classClass IOur severity:Critical FDA (Drugs)·D-1036-2020·Announced 2020-03-25

UP2 Libido Supplement Recalled for Undeclared Sildenafil

Med Man Distribution is recalling UP2 dietary supplements because FDA analysis found undeclared sildenafil, a prescription drug, in the product.

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 agency classification is FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The presence of undeclared sildenafil, a prescription drug, in a dietary supplement poses a significant risk of serious adverse health consequences, particularly for individuals with certain medical conditions or those taking other medications.

Plain-English summary

Med Man Distribution, Inc. is recalling UP2, a dietary supplement marketed as 'All Natural Libido for Men & Women.' The recall involves 1,680 cartons of the product, which are available in one-pack, four-pack, and ten-pack configurations. The product was distributed nationwide in the USA.

The recall was initiated because FDA analysis discovered that the product contains undeclared sildenafil. Sildenafil is a prescription medication, and the presence of this undeclared drug in a dietary supplement means the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

Consumers who have purchased UP2 supplements should stop using the product and contact Med Man Distribution, Inc. for further instructions or a refund. The recall covers all lots of the product.

The recalled product

Product: UP2, Dietary Supplement, All Natural Libido for Men & Women, a) one pack, b) four pack, c) ten pack capsules per carton, Exclusively Manufactured and Formulated by: Buy Wise Marketing, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783, Ultimatepleasure2.com.
Manufacturer: Med Man Distribution, Inc.
Category: Drug — Dietary Supplement
Hazard: undeclared-drug
sildenafil
Affected units: 1,680

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)

All lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Med Man Distribution, 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 2 products in this recall →

Same manufacturer · Med Man Distribution, Inc.

See all →

Severe
Bow and Arrow Libido Supplement Recalled for Undeclared Sildenafil
FDA (Drugs) · 2020-03-25

Same hazard · undeclared drug