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.
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 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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