Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. Recalled by Dermamedics, L.L.C. Due to Marketed without an Approved NDA/ANDA: FDA has determined...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Dermamedics, L.L.C. directly.
Affected Products
Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of DM1016 and 0.25 containers with a SKU number of PS 1016; and Therametics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of BR008.
Quantity: unknown
Why Was This Recalled?
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Dermamedics, L.L.C.
Dermamedics, L.L.C. has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report