Red Zone Xtreme 3000 Capsules Recalled for Undeclared Tadalafil
The FDA is recalling Red Zone Xtreme 3000 Capsules because FDA analysis found the product contains undeclared Tadalafil, an approved drug for erectile dysfunction.
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 Red Zone Xtreme 3000 Capsules, a dietary supplement product. The product is sold in 1-count blister packs containing 315 capsules, with a UPC of 8 91656 00200 9 and an expiration date of 12/31/2021. The recalling firm is Jimmy Weber.
The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analysis determined that the product contains undeclared Tadalafil, which is an FDA-approved drug used for the treatment of erectile dysfunction.
The product was distributed online via eBay. Consumers who have purchased this product should stop using it and contact the seller or the recalling firm for information on how to return the product or obtain a refund.
The recalled product
- Product
- Red Zone Xtreme 3000 Capsules, Dietary Supplement Product, 1 count blister pack, UPC 8 91656 00200 9, Exp Date 12/31/2021
- Manufacturer
- Jimmy Weber
- Category
- Drug — Dietary Supplement
- Hazard
- Affected units
- 315
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 (2)
- UPC # 891656002209
- exp date 12/31/2021
Distribution
Distribution scope not specified by the agency.
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