Olaax MAXILOSS Weight Advanced Recalled for Containing Unapproved Sibutramine
Olaax International is recalling MAXILOSS Weight Advanced capsules because they contain sibutramine, an unapproved drug removed from the U.S. market for safety reasons.
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
Olaax International is recalling MAXILOSS Weight Advanced, a 225 mg proprietary blend of herbs supplied in 36-count capsules in green and blue boxes. The product was formulated and distributed by Olaax Corp in Lakeland, Florida. The recall covers 600 boxes and all lots.
The recall was initiated because the product contains sibutramine, a previously approved FDA drug that was removed from the U.S. marketplace for safety reasons. Consequently, the product is considered an unapproved new drug marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The product was distributed nationwide, as well as in Puerto Rico, Venezuela, and Bolivia. Consumers should stop using the product and return it to the place of purchase for a refund or follow instructions from the recalling firm.
The recalled product
- Product
- MAXILOSS Weight Advanced, 225 mg proprietary blend of herbs, supplied in 36 count capsules in Green & Blue Boxes, Formulated and distributed by Olaax Corp, Lakeland, FL
- Manufacturer
- OLAAX International
- Category
- Drug — Dietary Supplement
- Affected units
- 600
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
Distribution
Related recalls
Same hazard · unapproved drug
See all →- CriticalBuy-Herbal Recalls Kian Pee Wan Capsules for Undeclared Drug Ingredients
FDA (Drugs) · 2026-08-19
- SevereMR. 7 Super capsules recalled as Class I over undeclared sildenafil
FDA (Drugs) · 2026-03-11
- SevereMojo Max Fusion capsules recalled as Class I over undeclared drug ingredients
FDA (Drugs) · 2026-03-11
- SevereSilintan herbal pills recalled as Class I for undeclared meloxicam
FDA (Drugs) · 2026-03-11
- SevereAgebox iKids-Growth Day Formula Capsules Recalled Over Undeclared Drug Ingredient
FDA (Drugs) · 2026-03-04
Similar recalls
- CriticalFDA Recalls Black Gold X Advanced Capsules for Undeclared Sibutramine
FDA (Drugs) · 2016-12-28
- CriticalLaBri's Body Health XPLODE Recalled for Unapproved Sibutramine
FDA (Drugs) · 2017-12-27
- CriticalBotanicalNow BodySlim Herbal Capsules Recalled for Undeclared Sibutramine
FDA (Drugs) · 2018-01-31
- CriticalSlim Xtreme Weight Loss Capsules Recalled for Undeclared Sibutramine Ingredients
FDA (Drugs) · 2014-06-18
- CriticalFDA Recalls LaBri's Body Health Atomic 60 Capsules for Sibutramine Contamination
FDA (Drugs) · 2017-12-27
- CriticalGlobe All Wellness Recalls Slim Xtreme Capsules Containing Unapproved Sibutramine
FDA (Drugs) · 2013-02-13