Flawless Beauty Recalls Relumins Vitamin C Ampules for Misbranding
Flawless Beauty LLC is voluntarily recalling all lots of Relumins Vitamin C Solvent ampules because they were marketed without an approved NDA or ANDA.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a voluntary action to address regulatory misbranding and unapproved status, without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Flawless Beauty LLC is voluntarily recalling all lots of Relumins Vitamin C Solvent ampules. The product was sold individually or as part of multi-unit kits and was distributed nationwide in the United States.
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), constituting misbranding and unapproved new drugs under the Federal Food, Drug, and Cosmetic Act.
Consumers who possess these products should stop using them and contact Flawless Beauty LLC for further instructions regarding the recall.
The recalled product
- Product
- Relumins Vitamin C Solvent ampules
- Manufacturer
- Flawless Beauty LLC
- Category
- Drug — Topical / Cosmetic
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
- SevereFlawless Beauty Recalls Tatiomax Glutathione Whitening Kits Nationwide
FDA (Drugs) · 2018-02-14
- SevereFlawless Beauty LLC Recalls Ling Zhi Capsules for Misbranding
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
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
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
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- SevereFlawless Beauty LLC Recalls Unapproved Injectable Glutathione Solution
FDA (Drugs) · 2014-05-21
- SevereFlawless Beauty Recalls Vitamin C Injection Sold Without FDA Approval
FDA (Drugs) · 2014-05-21
- ModerateFlawless Beauty LLC Recalls Laroscorbine Platinium Injectable Solution
FDA (Drugs) · 2014-05-21
- SevereFlawless Beauty Recalls Sterile Water for Injection Sold Without Approval
FDA (Drugs) · 2014-05-21
- ModerateFDA Recalls Unapproved Dermamedics and Therametics Topical Emulsions
FDA (Drugs) · 2014-08-06
- ModerateFDA Recalls Unapproved Vitamin B12 Injection Vials Nationwide
FDA (Drugs) · 2014-08-13