The Recall Desk
CriticalFDA (Drugs)·D-0971-2017·Announced 2017-07-19

LabidaMAX Herbal Supplement Recalled for Undeclared Prescription Drugs

Organic Herbal Supply is recalling LabidaMAX Herbal Dietary Supplement Capsules because FDA analysis found undeclared prescription drugs.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Organic Herbal Supply is voluntarily recalling LabidaMAX Herbal Dietary Supplement Capsules, 500 mg, in 30-count packages. The product is made in Malaysia and distributed nationwide via the internet. The recall covers all lots and package sizes.

The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analysis detected the presence of undeclared tadalafil, sildenafil, and/or their analogues, as well as Flibanserin. These are prescription medications that were not listed on the product label.

Consumers who have purchased this product should stop using it and return it to the place of purchase for a refund. The product is identified by UPC Code 680474228904.

The recalled product

Product
LabidaMAX Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY --- UPC Code 680474228904

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 and package sizes

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Organic Herbal Supply 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 11 products in this recall →