Agency classClass IOur severity:Critical FDA (Drugs)·D-0963-2017·Announced 2017-07-19

ZRECT Male Enhancement Supplement Recalled for Undeclared Prescription Drugs

Organic Herbal Supply is recalling ZRECT Male Enhancement capsules because FDA analysis found undeclared prescription drugs, including tadalafil and sildenafil.

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 or exposure to the violative product will cause serious adverse health consequences or death. The presence of undeclared prescription drugs in a dietary supplement is a critical safety hazard.

Plain-English summary

Organic Herbal Supply is recalling ZRECT Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, in 2, 4, and 10-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 can have serious side effects and interact with other drugs.

Consumers who have purchased this product should stop using it immediately. They should contact the distributor for a refund or further instructions. Because the product contains undeclared prescription drugs, it poses a significant health risk to consumers, particularly those taking other medications.

The recalled product

Product: ZRECT Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Roseville, CA --- UPC Code 852675999451
Manufacturer: Organic Herbal Supply
Category: Drug — Dietary Supplement
Hazard: undeclared-drug
adverse-reaction

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 →

Same manufacturer · Organic Herbal Supply

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Same hazard · undeclared drug