Drugplain

Effaclar 1 mg/g

Adapalene · GEL · LOreal USA Products Inc

3 Recalls on Record
Plain English

Effaclar is a gel containing adapalene at 1 mg/g, taken topical. Manufactured by LOreal USA Products Inc.

Key Facts

Brand Name
Effaclar
Generic Name
Adapalene
NDC Code (Product)
49967-591
Manufacturer
LOreal USA Products Inc
Strength
1 mg/g
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
ANDA091314
Drug Class
Retinoid [EPC]
Marketing Start
08/23/2019

Recall History

3 Recalls on Record
Class II03/05/2025

L'Oreal USA

cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.

OngoingVoluntary: Firm initiated
Class II03/05/2025

L'Oreal USA

cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.

OngoingVoluntary: Firm initiated
Class II03/05/2025

L'Oreal USA

Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective2,685 reports
dry skin855 reports
condition aggravated617 reports
rash555 reports
acne536 reports
skin burning sensation519 reports
erythema504 reports
skin irritation499 reports
pruritus394 reports
hypersensitivity344 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for the treatment of acne clears acne blemishes penetrates pores to control acne blemishes helps prevent new acne blemishes from forming

Dosage & Administration

Directions shake well before use clean the skin thoroughly before applying this product cover the entire affected area with a thin layer one to three times daily because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce application to once a day or every other day if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Warnings

Warnings For external use only

Frequently Asked Questions

What is Effaclar used for?

Effaclar contains Adapalene. It is a gel taken topical. Consult your doctor for specific uses.

Is Effaclar a controlled substance?

Effaclar is not classified as a controlled substance by the DEA.

What is the generic name for Effaclar?

The generic name for Effaclar is Adapalene. There are 12 other brand versions of Adapalene.

What is the NDC code for Effaclar 1 mg/g?

The NDC (National Drug Code) for Effaclar 1 mg/g is 49967-591, listed by LOreal USA Products Inc.