The Recall Desk
CriticalFDA (Drugs)·D-0625-2018·Announced 2018-04-04

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.

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

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.

Related recalls

Same hazard · undeclared drug

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