The Recall Desk
CriticalFDA (Drugs)·D-0909-2016·Announced 2016-06-01

Super Herbs 350 mg capsules recalled for undeclared active ingredients

Super Herbs 350 mg capsules are being recalled because they contain undeclared sibutramine, desmethylsibutramine, and/or phenolphthalein.

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

Super Herbs is recalling 9 bottles of SUPER HERBS 350 mg, 30 capsules per bottle. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

The recall is due to the presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine), and/or phenolphthalein. These ingredients were not declared on the product label.

The recall affects 9 consignees, with only 9 bottles distributed. Consumers should stop using the product and contact the recalling firm for instructions.

The recalled product

Product
SUPER HERBS 350 mg, 30 capsules per bottle.
Manufacturer
Super Herbs
Affected units
9

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

Distribution scope not specified by the agency.