FDA Recalls Black Label X Capsules for Undeclared Sildenafil
Making It a Lifestyle is recalling 1,000 bottles of Black Label X capsules nationwide because they contain undeclared sildenafil and were marketed without FDA 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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which indicates a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a severity score of 5.
Plain-English summary
Making It a Lifestyle is voluntarily recalling 1,000 bottles of Black Label X capsules, 60-count bottles, distributed nationwide. The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and contains undeclared sildenafil.
Sildenafil is an active pharmaceutical ingredient used to treat erectile dysfunction and pulmonary arterial hypertension. The presence of undeclared sildenafil in a product marketed without FDA approval poses a safety risk to consumers who may not be aware of the medication's presence or potential interactions with other drugs.
Consumers who have purchased Black Label X capsules should stop using the product immediately and contact their healthcare provider if they have any concerns or questions about the medication. The recall covers all lots of the product.
The recalled product
- Product
- BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
- Manufacturer
- Making It a Lifestyle
- Category
- Drug — Supplement
- Affected units
- 1,000
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.
Part of a larger recall action
This product is one of 3 recalled by Making It a Lifestyle 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 3 products in this recall →Related recalls
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