FDA Recalls Unapproved Ligandrol Supplements Sold Nationwide and in Brazil
Invisiblu International LLC is recalling LGD-Xtreme capsules containing unapproved ligandrol because the product was marketed without an approved NDA or 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, particularly given the presence of an unapproved active pharmaceutical ingredient.
Plain-English summary
Invisiblu International LLC is recalling LGD-Xtreme (ligandrol LGD-4033) capsules, 3 mg, 90-count bottles. The product was manufactured for Continuum Labs in Fort Lauderdale, FL. The recall involves 3,319 bottles with Lot # 21511166 and an expiration date of 11/18.
The FDA is recalling this product because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The product contains an unapproved drug, ligandrol LGD-4033.
The product was distributed nationwide and in Brazil. Consumers should stop using the product and contact the recalling firm for instructions on disposal or return.
The recalled product
- Product
- LGD-Xtreme (ligandrol LGD-4033),capsules, 3 mg, 90-count bottle, Manufactured for Continuum Labs, Fort Lauderdale, FL
- Manufacturer
- Invisiblu International LLC
- Category
- Drug — Unapproved Supplement
- Hazard
- Affected units
- 3,319
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 (2)
- Lot # 21511166
- Exp 11/18
Distribution
Distributed nationwide across the United States.
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