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.
What this means for you
Illness, injury, or structural failure has been reported. 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
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.
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