The Recall Desk
CriticalFDA (Drugs)·D-0867-2017·Announced 2017-05-31

Envy Me Recalls LaBri's Body Health Atomic Due to Undeclared Sibutramine

Envy Me is recalling LaBri's Body Health Atomic capsules because the product contains undeclared Sibutramine and was marketed without an approved NDA/ANDA.

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 corresponds to a Critical severity score of 5 according to the rubric.

Plain-English summary

Envy Me is recalling LaBri's Body Health Atomic, 60 capsules, because the product contains undeclared Sibutramine. The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

The product was sold nationwide through internet sales. No foreign consignees were reported. The recall includes all lot codes, manufacturing codes, and expiration dates.

Consumers should stop using the product and contact Envy Me for further instructions or a refund.

The recalled product

Product
LaBri's Body Health Atomic, 60 capsules
Manufacturer
Envy Me
Category
Drug — Dietary 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 (2)

  • All lot codes
  • manufacturing codes and expiration dates.

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · undeclared ingredient

See all →