Flawless Beauty Recalls Sterilized Water for Injections Due to Misbranding
Flawless Beauty LLC is voluntarily recalling all lots of sterilized water for injections sold in the U.S. because the products were marketed without FDA approval.
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 agency classification is FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the products are unapproved new drugs marketed without NDA/ANDA approval.
Plain-English summary
Flawless Beauty LLC is voluntarily recalling all lots of sterilized water for injections BP, 50 x 5 mL plastic ampules, manufactured in India. The product was distributed nationwide in the United States, either sold 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 FDA 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 the recalling firm for further instructions. The recall covers all lots of the affected products.
The recalled product
- Product
- Sterilized water for injections BP, 50 x 5 mL plastic ampules, Manufactured in India
- Manufacturer
- Flawless Beauty LLC
- Category
- Drug — Unapproved New Drug
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 LLC Recalls Ling Zhi Capsules for Misbranding
FDA (Drugs) · 2018-02-14
- SevereFlawless Beauty Recalls Unapproved Saluta Glutathione Whitening Kits Nationwide
FDA (Drugs) · 2018-02-14
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
- SevereFlawless Beauty Recalls Sterile Water for Injection Sold Without Approval
FDA (Drugs) · 2014-05-21
- SevereFlawless Beauty Recalls Vitamin C Injection Sold Without FDA Approval
FDA (Drugs) · 2014-05-21
- ModerateFDA Recalls Unapproved Dermamedics and Therametics Topical Emulsions
FDA (Drugs) · 2014-08-06
- SevereFranck's Lab Recalls Sterile Injectable Water Due to Contamination
FDA (Drugs) · 2012-08-22
- SeverePharm D Solutions Recalls Sterile Water Bags Due to Sterility Concerns
FDA (Drugs) · 2018-11-07
- ModerateMedical Supply Liquidators Recalls Unapproved MIC Injection Vials
FDA (Drugs) · 2014-08-13