Complexion Repair Emulsion (Dermamedics) – unapproved drug (2014)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 distributed in 50 ml containers with a SKU number of CR002 and in 50 ml containers in the Therametics Complexion Repair Acne Treatment System Kit with a SKU number of CR1005; and in 30 ml containers in the Therametics Comple
Brand
Dermamedics, L.L.C.
Lot Codes / Batch Numbers
all lot codes 30 ml and 50 ml
Products Sold
all lot codes 30 ml and 50 ml
Dermamedics, L.L.C. is recalling Dermamedics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Derm due to Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026