The Recall Desk
SevereFDA (Drugs)·D-0206-2024·Announced 2024-01-03

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Hazard
  • undeclared-active-ingredient
  • sildenafil
  • unapproved-drug

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.