CLASS II Drug recall · Reported 6 Aug 2014 · FDA Enforcement Report

Baby's Relief Calm and Repair Cream in containers recalled

Dermamedics is recalling Baby's Relief Calm and Repair Cream in containers with a, distributed nationwide in the US. The recall was initiated on 10 Jan 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesall lot codes

Quantity recalledunknown

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1489-2014
FDA event ID: 67247
Recalling firm: Dermamedics, Oklahoma City, OK
Classification: Class II
Status: Terminated
Recall initiated: 10 Jan 2014
FDA classified: 29 Jul 2014
Reported: 6 Aug 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Drug class: Creams, Ointments & Gels

Timeline

10 Jan 2014	Recall initiated by company
29 Jul 2014	Classified by FDA	+200 days
6 Aug 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

all lot codes

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

8 other products · FDA event 67247

This product is part of a recall event; the main page for the event is Post Procedure Cream containers which were distributed recalled.

Reported	Class	Recall	Company	Reason	Where
6 Aug 2014	CLASS II	Post Procedure Cream containers which were distributed recalled	Dermamedics	Labeling Errors	Nationwide
6 Aug 2014	CLASS II	Complexion Repair Topical Rehydrating Emulsion recalled by Dermamedics	Dermamedics	Labeling Errors	Nationwide
6 Aug 2014	CLASS II	Calm and Correct Cream containers recalled by Dermamedics	Dermamedics	Labeling Errors	Nationwide
6 Aug 2014	CLASS II	Therametics Complexion Repair Topical Rehydrating Emulsion recalled	Dermamedics	Labeling Errors	Nationwide
6 Aug 2014	CLASS II	Calm & Correct Cream in containers recalled by Dermamedics	Dermamedics	Labeling Errors	Nationwide
6 Aug 2014	CLASS II	Complexion Repair Topical Rehydrating Emulsion recalled by Dermamedics	Dermamedics	Labeling Errors	Nationwide
6 Aug 2014	CLASS II	Post Procedure Cream containers recalled by Dermamedics	Dermamedics	Labeling Errors	Nationwide
6 Aug 2014	CLASS II	Calm and Correct Serum containers recalled by Dermamedics	Dermamedics	Labeling Errors	Nationwide

More recalls from Dermamedics

All 9

Reported	Class	Recall	Company	Reason	Where
6 Aug 2014Drug	CLASS II	Calm and Correct Serum containers recalled by Dermamedics	Dermamedics	Labeling Errors	Nationwide
6 Aug 2014Drug	CLASS II	Post Procedure Cream containers recalled by Dermamedics	Dermamedics	Labeling Errors	Nationwide
6 Aug 2014Drug	CLASS II	Complexion Repair Topical Rehydrating Emulsion recalled by Dermamedics	Dermamedics	Labeling Errors	Nationwide
6 Aug 2014Drug	CLASS II	Calm & Correct Cream in containers recalled by Dermamedics	Dermamedics	Labeling Errors	Nationwide
6 Aug 2014Drug	CLASS II	Therametics Complexion Repair Topical Rehydrating Emulsion recalled	Dermamedics	Labeling Errors	Nationwide