Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Jan 10, 2014 (13 years ago)

Dermamedics Calm & Correct Cream in 2 oz. containers with SKU…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

Cause type: Unapproved drug

The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.

What was recalled

Dermamedics Calm & Correct Cream in 2 oz. containers with SKU number DM1020.

Recalling firm
Dermamedics, L.L.C.
Origin
OK, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1488-2014 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other recalls by Dermamedics, L.L.C.

All 2014 recalls

Other unapproved drug recalls from 2014

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