Dermamedics Calm & Correct Cream Recalled for Lack of FDA Approval
Dermamedics, L.L.C. is recalling Calm & Correct Cream because the FDA determined the product is an unapproved new drug 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, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.
Plain-English summary
Dermamedics, L.L.C. is recalling Dermamedics Calm & Correct Cream in 2 oz. containers with SKU number DM1020. The recall includes all lot codes and both .25 oz and 2 oz sizes. The product was distributed nationwide.
The FDA determined that the products are unapproved new drugs and misbranded because they were marketed without an Approved NDA/ANDA. No specific injuries or illnesses were reported in the source text.
Consumers should stop using the recalled product. The recalling firm, Dermamedics, L.L.C., is responsible for the recall.
The recalled product
- Product
- Dermamedics Calm & Correct Cream in 2 oz. containers with SKU number DM1020.
- Manufacturer
- Dermamedics, L.L.C.
- Category
- Drug — Topical Cream
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 (2)
- all lot codes
- .25 oz and 2 oz sizes
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
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