The Recall Desk
SevereFDA (Drugs)·D-0333-2018·Announced 2018-02-14

Flawless Beauty LLC Recalls Ling Zhi Capsules for Misbranding

Flawless Beauty LLC is voluntarily recalling all lots of Ling Zhi capsules because they were marketed without an approved NDA/ANDA, constituting misbranding and unapproved new drugs.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating (score 4) under the provided rubric, as it involves a product that may cause temporary or medically reversible adverse health consequences.

Plain-English summary

Flawless Beauty LLC is voluntarily recalling all lots of Ling Zhi capsules. The product was distributed nationwide in the United States, sold either individually or as part of multi-unit kits.

The recall is being conducted in accordance with a Consent Decree of Permanent Injunction ordered by the United States District Court. The agency determined that the products were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This action addresses violations of the Federal Food, Drug, and Cosmetic Act regarding misbranding and unapproved new drugs.

Consumers who possess these products should stop using them and contact the recalling firm for further instructions.

The recalled product

Product
Ling Zhi capsules

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

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by Flawless Beauty LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →