FDA Recalls ZRECT for Women Herbal Supplement Due to Undeclared Drugs
Organic Herbal Supply is recalling ZRECT for Women herbal capsules because FDA testing 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 mandates a severity score of 5 according to the rubric.
Plain-English summary
Organic Herbal Supply is voluntarily recalling ZRECT for Women Herbal Dietary Supplement Capsules, 500 mg, in 30-count packages. The product is distributed nationwide via the internet. The recall covers all lots and package sizes.
The FDA is classifying this as a Class I recall 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 active ingredients in prescription medications.
Consumers should stop using the product immediately and return it to the place of purchase for a refund. Individuals taking other medications, particularly for heart conditions or blood pressure, should consult their healthcare provider if they have already used this product, as the undeclared ingredients may interact with other drugs.
The recalled product
- Product
- ZRECT for Women Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 count packages, Distributed by Organic Herbal Supply, Roseville, CA --- UPC Code 680474229055
- Manufacturer
- Organic Herbal Supply
- Category
- Drug — Dietary Supplement
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.
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