Dietary supplement found to contain undeclared pharmaceutical drug tadalafil
Launch Sequence Capsules dietary supplement recalled for containing undeclared tadalafil, an FDA-approved pharmaceutical ingredient. The product was marketed without required drug approval.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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: This recall meets FDA Class I criteria, which establishes a minimum severity threshold of 4. The product contains an undeclared pharmaceutical ingredient marketed without required drug approval, posing serious regulatory and health hazards.
Plain-English summary
Launch Sequence Capsules, sold in 60-count bottles by Loud Muscle Science, are being recalled due to the presence of undeclared tadalafil. Tadalafil is an active pharmaceutical ingredient found in FDA-approved drugs used for male sexual enhancement.
The product was marketed as a dietary supplement without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), making it an unapproved drug. This recall affects 5,421 bottles distributed nationwide in the USA and Canada, including Lot# 20212001 with an expiration date of 12/2024.
Consumers who have purchased this product should discontinue use immediately. Anyone who has consumed the product and experiences any adverse effects should consult a healthcare provider. The product should be returned to the point of purchase or disposed of properly.
The recalled product
- Product
- Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375.
- Manufacturer
- Loud Muscle Science
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# 20212001
- Exp. Date 12/2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Loud Muscle Science 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 6 products in this recall →Related recalls
Same manufacturer · Loud Muscle Science
See all →- SevereLaunch Sequence Aphrodisia Capsules recalled for undeclared tadalafil
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- SevereFDA Recalls Launch Sequence Euphoria Capsules for Undeclared Tadalafil
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- HighDietary Supplement Marketed as Unapproved Drug Recalled by FDA
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- ModerateFDA Recalls Launch Sequence Euphoria Capsules as Unapproved Drug
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- HighLoud Muscle Science Recalls Unapproved Capsule Product Marketed as Aphrodisia
FDA (Drugs) · 2022-07-27
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