Thorne Research Recalls Captomer Capsules Marketed Without FDA Approval
Thorne Research is recalling Captomer capsules because they are marketed as dietary supplements but contain DMSA, an active drug ingredient, making them 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. The hazard involves marketing a product as a supplement when it contains an active drug ingredient, which is a regulatory and labeling issue without reported injuries or illnesses in the source text.
Plain-English summary
Thorne Research, Inc. is recalling Captomer [succinic acid (from 100 mg DMSA)] capsules, 65 mg, 45-count bottles. The product is identified by UPC 6 93749 74002 5. The recall includes all lot codes.
The recall is being conducted because Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA). DMSA is the active ingredient in an FDA-approved drug. Consequently, these products are considered unapproved new drugs rather than dietary supplements.
The product was distributed nationwide as well as in New Zealand, England, Germany, Sweden, Ukraine, and Egypt. Consumers should stop using the product and contact the manufacturer for further instructions.
The recalled product
- Product
- Captomer [succinic acid (from 100 mg DMSA)] capsules, 65 mg, 45-count bottles, Manufactured By: Thorne Research, Inc., P.O. Box 25, Dover, Idaho 83825, UPC 6 93749 74002 5
- Manufacturer
- Thorne Research Inc
- 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 lot codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Thorne Research Inc 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 2 products in this recall →Related recalls
Same manufacturer · Thorne Research Inc
See all →- ModerateThorne Research Recalls Captomer-250 Capsules Marketed Without Approval
FDA (Drugs) · 2014-06-25
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