MegMan Performance Booster capsules recalled for undeclared tadalafil
Junp Hydration LLC is recalling MegMan Performance Booster 800 mg capsules because the product contains undeclared tadalafil, an active pharmaceutical ingredient not listed on the label, making it an unapproved drug.
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: The FDA has classified this recall as Class I, which per the rubric requires a minimum score of 4. An undeclared active pharmaceutical ingredient (tadalafil) in an unapproved drug product presents a serious risk of harm, particularly since consumers are unaware they are ingesting a prescription-strength ingredient with potential interactions and contraindications.
Plain-English summary
Junp Hydration LLC is recalling MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters in cartons. The product was found to contain undeclared tadalafil, an ingredient found in FDA-approved products for the treatment of male sexual enhancement. Because tadalafil is not declared on the product label, this product is marketed as an unapproved drug.
The recalled product was distributed nationwide in the USA via Amazon Marketplace. The affected product has UPC 8 48998 00091 2 and ASIN B08Z74KS88, with Lot # 2010291 and expiration date 01/07/2024. A total of 750 cartons were distributed.
Consumers who have purchased this product should stop using it and contact the manufacturer or their healthcare provider if they have questions or have experienced any adverse reactions.
The recalled product
- Product
- MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters packaged in a carton, UPC 8 48998 00091 2, ASIN B08Z74KS88
- Manufacturer
- Junp Hydration LLC
- Affected units
- 750
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 # 2010291
- Exp 01/07/2024
Distribution
Distributed nationwide across the United States.
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