Supplement Capsules Recalled for Undeclared Sildenafil Content Nationwide
Magnum XXL 9800 capsules contain undeclared sildenafil and were marketed without FDA approval. The product was distributed nationwide via Amazon.
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: FDA Class I recall of unapproved drug with undeclared active pharmaceutical ingredient (sildenafil). Per the severity rubric, FDA Class I recalls must receive a score of at least 4.
Plain-English summary
Magnum XXL 9800 capsules, containing 2000 mg per capsule and packaged in blister packs, have been recalled. The product was distributed nationwide in the United States and sold through Amazon's Marketplace by Meta Herbal.
The recall was issued because the product contains an undeclared active pharmaceutical ingredient, sildenafil, and was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This means consumers purchased and potentially used a drug product without FDA approval and without knowing they were taking a pharmaceutical ingredient.
Consumers who purchased this product should stop using it. Those with questions or concerns about their health after using this product should contact their healthcare provider.
The recalled product
- Product
- Magnum XXL 9800, 2000 mg per capsule, 1 capsule per blister pack, Distributed by Magnum Los Angelas CA. UPC 6 45759 99300 7. Amazon's ASIN# B07P7ZH797, B07P94J3ZT, B07P6VK6N3, B076HNPZZZ
- Manufacturer
- Meta Herbal
- Affected units
- 500
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.
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