Thorne Research Recalls Captomer-250 Capsules Marketed Without Approval
Thorne Research is recalling Captomer-250 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, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.
Plain-English summary
Thorne Research, Inc. is recalling Captomer-250 [succinic acid (from 250 mg DMSA)] capsules, 162 mg, 45-count bottles. The product is identified by UPC 6 93749 73502 1 and 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, which classifies these products as unapproved new drugs rather than dietary supplements.
The products were distributed nationwide as well as in New Zealand, England, Germany, Sweden, Ukraine, and Egypt. Consumers should stop using the product and contact Thorne Research for further instructions.
The recalled product
- Product
- Captomer-250 [succinic acid (from 250 mg DMSA)] capsules, 162 mg, 45-count bottles, Manufactured By: Thorne Research, Inc., P.O. Box 25, Dover, Idaho 83825, UPC 6 93749 73502 1
- Manufacturer
- Thorne Research Inc
- Category
- Drug — Dietary Supplement
- 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 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 Capsules Marketed Without FDA Approval
FDA (Drugs) · 2014-06-25
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