FDA Recalls Unapproved Dermamedics and Therametics Topical Emulsions
Dermamedics, L.L.C. is recalling specific Complexion Repair Topical Rehydrating Emulsions because the FDA determined they are unapproved new drugs and misbranded.
What this means for you
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 the source text identifies the hazard as marketing without an approved NDA/ANDA (misbranding) rather than a specific physical or chemical contamination with reported injuries.
Plain-English summary
Dermamedics, L.L.C. is recalling Dermamedics Complexion Repair Topical Rehydrating Emulsion and Therametics Complexion Repair Topical Rehydrating Emulsion. The recalled products are available in 50 ml and 30 ml containers, including those found in Acne Treatment System Kits and Acne Travel Kits. The recall covers all lot codes for the 30 ml and 50 ml containers.
The FDA has 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). The distribution pattern for these products is nationwide.
Consumers who have these products should stop using them and contact the recalling firm for further instructions.
The recalled product
- Product
- Dermamedics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Dermamedics Complexion Repair Acne Treatment System Kit with SKU numbers of DM 1013 and DM 1025, respectively; Therametics Complexion Repair Topical Rehydrating Emulsion which was dist
- 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.
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