FDA Recalls Pain Stopper Capsules Due to Unapproved New Drug Status
Herbal Doctor Remedies is recalling Pain Stopper 500mg capsules because they are misbranded as unapproved new drugs.
What this means for you
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 as an unapproved new drug without reporting specific injuries or illnesses, aligning with the Moderate severity criteria for regulatory non-compliance without immediate physical harm reports.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Pain Stopper, 500mg Capsules, 90-count bottles. The product is distributed by Herbal Doctor Remedies, located in Alhambra, California.
The recall was initiated because the products were found to be misbranded as unapproved new drugs. This classification indicates that the products do not meet the regulatory requirements for marketing as drugs in the United States.
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 their expiry dates 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
- Pain Stopper, 500mg Capsules, 90-count bottle, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
- Manufacturer
- Herbal Doctor Remedies
- Category
- Drug — Dietary Supplement
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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