UPROAR Male Enhancement Supplement Recalled for Undeclared Prescription Drugs
Organic Herbal Supply is recalling UPROAR male enhancement 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 indicates a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or the death. The rubric mandates a score of 5 for FDA Class I recalls.
Plain-English summary
Organic Herbal Supply is recalling UPROAR All Natural Male Enhancement Herbal Dietary Supplement Capsules. The product is distributed by AH Distribution in Delray Beach, Florida, and was sold nationwide via the internet in 2, 4, and 10-count packages. 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 purchased UPROAR All Natural Male Enhancement Herbal Dietary Supplement Capsules should stop using the product immediately. The presence of undeclared prescription drugs in a dietary supplement poses a risk of adverse health effects, particularly for individuals taking other medications or with specific medical conditions. Consumers should contact the distributor or manufacturer for further instructions on disposal or return.
The recalled product
- Product
- UPROAR All Natural Male Enhancement Herbal Dietary Supplement Capsules, supplied in 2, 4 and 10 count packages, Distributed by AH Distribution, DelRay, Beach, FL ---- UPC Code 680474229260
- 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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