Adam's Secret Extra Strength 3000 Recalled for Unapproved Ingredients
The FDA is recalling Adam's Secret Extra Strength 3000 because it contains unapproved drugs 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
The U.S. Food and Drug Administration (FDA) is recalling Adam's Secret Extra Strength 3000, 840 mg, 10 count blister packs. The product is distributed by AS Inc. and made in the USA. The recall covers all lots within expiry and was distributed nationwide in the USA.
The recall was initiated because FDA analysis results indicated the presence of tadalafil and sildenafil in the product. These ingredients were not approved in the New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) for this product.
Consumers who have purchased this product should stop using it and contact the recalling firm, Adams.Secret.co, for further instructions.
The recalled product
- Product
- Adam's Secret Extra Strength 3000, 840 mg, 10 count blister packs, Distributed by AS Inc., Made in USA, UPC 6 09728 43452 6.
- Manufacturer
- Adams.Secret.co
- Category
- Drug — Supplement
- Hazard
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 within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Adams.Secret.co 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 2 products in this recall →Related recalls
Same manufacturer · Adams.Secret.co
See all →- CriticalAdam's Secret Extra Strength Recalled for Unapproved Active Ingredients
FDA (Drugs) · 2021-03-31
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