Entropic Labs SARM RAD-140 Recalled for Lack of FDA Approval
Entropic Labs is recalling SARM RAD-140 capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
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 rating under the rubric. The product contains unapproved SARMs, posing a significant health risk due to the lack of safety and efficacy data.
Plain-English summary
Tuscano and Delucia Group (DBA Entropic Labs) is recalling Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles. The product is identified by the UPC number 651074545302. The recall covers 60 units distributed nationwide within the United States.
The FDA has determined that the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The product contains Selective Androgen Receptor Modulators (SARMs), which are not approved for human consumption by the FDA.
Consumers who have purchased this product should stop using it immediately. The source text does not specify a return address or refund procedure, but consumers are advised to discontinue use of the unapproved product.
The recalled product
- Product
- Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles, Entropic Labs UPC#: 651074545302
- Manufacturer
- Tuscano and Delucia Group (DBA Entropic Labs)
- Category
- Drug — Unapproved Supplement
- Hazard
- Affected units
- 60
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
Distribution
Distributed nationwide across the United States.
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