Dietary Supplement Marketed as Unapproved Drug Recalled by FDA
Launch Sequence Capsules, a dietary supplement sold in 60-count bottles, were recalled because they were marketed without FDA approval as a drug based on label claims.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of an unapproved drug marketed without proper regulatory approval. While no illnesses or injuries have been reported, unapproved drugs with unsubstantiated claims represent unknown safety risks to consumers.
Plain-English summary
Launch Sequence Capsules, manufactured by Loud Muscle Science, are being recalled. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). According to the FDA, the product's label claims made it subject to drug regulations, but no such approval was obtained before marketing.
The recalled product includes 2,495 units of 60-count bottles distributed nationwide in the USA and Canada. Affected lot numbers include C07172101 (expiring 07/2024) and 2022054 (expiring 03/2025). The product is identified by ASIN B07TLPWXDS and UPC Code 641378938375.
Consumers who have purchased this product should consult the FDA's drug recall database or contact their healthcare provider for guidance. Those who have used the product and have concerns should speak with a healthcare professional.
The recalled product
- Product
- Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375.
- Manufacturer
- Loud Muscle Science
- Hazard
- unapproved-drug
- unsubstantiated-claims
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 (4)
- Lot# C07172101
- Exp date: 07/2024
- 2022054
- Exp date: 03/2025
Distribution
Distributed nationwide across the United States.
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