The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1151-2020·Announced 2020-04-15

Herbal Doctor Remedies Recalls Pimples Off Solution for Misbranding

Herbal Doctor Remedies is recalling Pimples Off Solution because the product is misbranded as an unapproved new drug.

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, and the source text identifies the issue as misbranding without reporting specific injuries or illnesses, aligning with the Moderate severity criteria for labeling or regulatory compliance issues.

Plain-English summary

Herbal Doctor Remedies is recalling Pimples Off Solution 60 ML. The recall was initiated because the products were found to be misbranded as unapproved new drugs.

The affected products were sold online within the United States and internationally to Australia, Canada, Israel, Italy, Japan, Norway, and the United Kingdom. All lots within expiry are included in this recall.

Consumers should stop using the product and contact Herbal Doctor Remedies at 1(800) 600-0808 for further instructions.

The recalled product

Product
Pimples Off Solution 60 ML, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600- 0808
Manufacturer
Herbal Doctor Remedies
Category
Drug — Topical
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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