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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Manufacturer
- Flawless Beauty LLC
- Category
- Drug — Supplement
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 →Related recalls
Same manufacturer · Flawless Beauty LLC
See all →- HighFlawless Beauty Recalls Relumins Advanced Glutathione Kits Nationwide
FDA (Drugs) · 2018-02-14
- ModerateFlawless Beauty Recalls Relumins Vitamin C Ampules for Misbranding
FDA (Drugs) · 2018-02-14
- SevereFlawless Beauty Recalls Tatiomax Glutathione Whitening Kits Nationwide
FDA (Drugs) · 2018-02-14
- SevereFlawless Beauty Recalls Sterilized Water for Injections Due to Misbranding
FDA (Drugs) · 2018-02-14
- SevereFlawless Beauty Recalls Unapproved Saluta Glutathione Whitening Kits Nationwide
FDA (Drugs) · 2018-02-14
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- SevereFDA Recalls Unapproved Zhong Hua Niu Bian Capsules Nationwide
FDA (Drugs) · 2016-06-01
- SevereFDA Recalls Bull Capsules Marketed Without FDA Approval
FDA (Drugs) · 2016-06-01
- SevereFDA Recalls Zhen Gong Fu for Lack of Approved New Drug Application
FDA (Drugs) · 2016-06-01
- CriticalZI XIU TANG Beauty Capsules Recalled for Undeclared Sibutramine
FDA (Drugs) · 2016-07-13
- SevereFUCONPO Capsule Recalled for Marketing Without Approved NDA or ANDA
FDA (Drugs) · 2016-07-20
- SevereAndropharm Sten Z capsules recalled for lack of FDA approval
FDA (Drugs) · 2017-09-20