The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1107-2020·Announced 2020-04-15

Acne Off Recalled for CGMP Deviations and Misbranding as Unapproved New Drug

Herbal Doctor Remedies is recalling Acne Off because the product was found to be misbranded as an unapproved new drug due to CGMP deviations.

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 involves a temporary or medically reversible adverse health consequence. The source text cites misbranding and CGMP deviations without reporting specific injuries or illnesses, aligning with a Moderate severity rating.

Plain-English summary

Herbal Doctor Remedies is voluntarily recalling Acne Off, a product distributed from Alhambra, California. The recall was initiated because the product was found to be misbranded as an unapproved new drug, a determination linked to Current Good Manufacturing Practice (CGMP) deviations.

The affected products are sold online within the United States and internationally to Australia, Canada, Israel, Italy, Japan, Norway, and the United Kingdom. The recall covers all lots within their expiry dates.

Consumers who have purchased Acne Off should stop using the product. They can contact Herbal Doctor Remedies at 1(800) 600-0808 for further information regarding the recall.

The recalled product

Product
Acne Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Manufacturer
Herbal Doctor Remedies
Category
Drug — Topical Acne Treatment
Hazard

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 (1)

  • All lots within expiry

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 70 recalled by Herbal Doctor Remedies 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 70 products in this recall →

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