The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1131-2020·Announced 2020-04-15

FDA Recalls Hernia Off for Unapproved New Drug Status

Herbal Doctor Remedies is recalling Hernia Off 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, which corresponds to a 'Severe' severity score (4) according to the rubric.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Hernia Off, a product distributed by Herbal Doctor Remedies. The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically that the products have been found to be misbranded as unapproved new drugs.

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 includes all lots within their expiry dates.

Consumers who have purchased Hernia Off should stop using the product and contact the distributor for further instructions.

The recalled product

Product
Hernia Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Manufacturer
Herbal Doctor Remedies
Category
Drug — Unapproved New Drug
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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