ForeverMen Natural Energy Boost Capsules Recalled for Undeclared Sildenafil
ForeverMen Natural Energy Boost Capsules contain undeclared sildenafil and are marketed without FDA approval, making them an unapproved drug. Consumers should stop using the product immediately.
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 requires a minimum severity score of 4. No deaths, serious injuries, or hospitalizations have been reported. However, the undeclared presence of a prescription pharmaceutical in an unapproved product presents significant risk of adverse effects and drug interactions.
Plain-English summary
ForeverMen Natural Energy Boost Capsules have been recalled due to the presence of undeclared sildenafil, a pharmaceutical ingredient not listed in the product labeling or ingredient list. The product is marketed and sold without an FDA-approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Sildenafil is a prescription drug approved by the FDA for male sexual enhancement in regulated pharmaceutical products. The presence of an undeclared pharmaceutical ingredient in an unapproved product poses health risks, as consumers may unknowingly ingest a prescription-strength drug that could interact with other medications or cause adverse effects.
The recalled product was distributed nationwide in the United States through Amazon Marketplace. All lots currently within their expiration date are included in the recall. Consumers who have purchased ForeverMen Natural Energy Boost Capsules should stop using the product immediately. Anyone who has consumed the product and experiences adverse effects should consult with a healthcare provider.
The recalled product
- Product
- ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.
- Manufacturer
- FA Online Inc
- Category
- Drug — Dietary Supplement
- Affected units
- 400
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 within expiry
Distribution
Distributed nationwide across the United States.
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