The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0967-2017·Announced 2017-07-19

FDA Recalls ZDaily Testosterone Supplement for Undeclared Prescription Drugs

Organic Herbal Supply is recalling ZDaily Testosterone and Libido Booster capsules because FDA analysis found undeclared prescription drugs, including tadalafil, sildenafil, and flibanserin.

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 prescription drugs in a supplement is a severe hazard.

Plain-English summary

Organic Herbal Supply is voluntarily recalling ZDaily Daily Testosterone and Libido Booster Herbal Dietary Supplement Capsules, 500 mg. The product is supplied in 2, 4, and 10 count packages and was distributed nationwide via the internet. The recall covers all lots and package sizes.

The FDA is recalling the product because it 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 immediately. The presence of undeclared prescription drugs in a dietary supplement poses significant health risks, particularly for individuals taking other medications or those with specific medical conditions. Consumers should contact the distributor for further information or a refund.

The recalled product

Product
ZDaily Daily Testosterone and Llibido Booster Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Distributed by Organic Herbal Supply, Roseville, CA --- UPC Code 680474229062

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 →

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