Dermamedics Recalls Unapproved Therametics Complexion Repair Topical Emulsion
Dermamedics, L.L.C. is recalling Therametics Complexion Repair Topical Rehydrating Emulsion because the FDA determined the products are unapproved new drugs and misbranded.
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 due to regulatory non-compliance (unapproved/misbranded status) rather than a specific physical hazard or reported injury, aligning with the Moderate severity criteria for labeling and regulatory issues.
Plain-English summary
Dermamedics, L.L.C. is recalling Therametics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers. The affected products are part of the Complexion Repair Acne Treatment System Kit and the Complexion Repair Acne Travel Kit, with SKU numbers CR1005 and CR1007, respectively. The recall covers all lot codes for both container sizes and was distributed nationwide.
The U.S. Food and Drug Administration (FDA) determined that these products are unapproved new drugs and misbranded because they were marketed without an Approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This is an FDA Class II recall.
Consumers who have these products should stop using them and contact Dermamedics, L.L.C. for further instructions or a refund.
The recalled product
- Product
- Therametics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Complexion Repair Acne Treatment System Kit and the Complexion Repair Acne Travel Kit with SKU numbers of CR1005 and CR1007, respectively.
- Manufacturer
- Dermamedics, L.L.C.
- Category
- Drug — Topical
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 lot codes 30 ml and 50 ml
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Dermamedics, L.L.C. 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 9 products in this recall →Related recalls
Same manufacturer · Dermamedics, L.L.C.
See all →- ModerateDermamedics Serum Recalled for Lacking FDA Approval
FDA (Drugs) · 2014-08-06
- ModerateFDA Recalls Unapproved Dermamedics and Therametics Topical Emulsions
FDA (Drugs) · 2014-08-06
- ModerateFDA Recalls Unapproved Dermamedics and Therametics Topical Emulsions
FDA (Drugs) · 2014-08-06
- ModerateDermamedics Post Procedure Cream Recalled for Lack of FDA Approval
FDA (Drugs) · 2014-08-06
- ModerateDermamedics Post Procedure Cream Recalled for Lack of FDA Approval
FDA (Drugs) · 2014-08-06
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
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- HighHerbal Doctor Remedies Recalls Dermamycin Capsules for Unapproved New Drug Status
FDA (Drugs) · 2020-04-15
- ModerateHerbal Doctor Remedies Recalls Skin Cleanser Capsules for Misbranding
FDA (Drugs) · 2020-04-15
- SevereFlawless Beauty Recalls Unapproved Glutathione Injectable Products Nationwide
FDA (Drugs) · 2018-02-14
- ModerateHerbal Doctor Remedies Recalls Dermatoxin Capsules Due to Misbranding
FDA (Drugs) · 2020-04-15
- ModerateHerbal Doctor Remedies Recalls Skin Moist Capsules for CGMP Deviations
FDA (Drugs) · 2020-04-15
- HighFlawless Beauty Recalls Relumins Advanced Glutathione Kits Nationwide
FDA (Drugs) · 2018-02-14