The Recall Desk
SevereFDA (Drugs)·D-0797-2021·Announced 2021-09-22

Hydro Pineapple Burn Max Health Supplement Recalled for Undeclared Sibutramine

Hydro Pineapple Burn Max Health supplement sachets are being recalled because they contain undeclared sibutramine and were marketed without FDA approval. The product was distributed nationwide.

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: The FDA classified this as a Class I drug recall for an unapproved drug containing an undeclared pharmaceutical ingredient (sibutramine). Per the rubric, FDA Class I recalls are scored at minimum 4 (Severe).

Plain-English summary

Hydro Pineapple Burn Max Health Thach Dua, a supplement product packaged in boxes containing 20g sachets (35 boxes total), is being recalled due to the presence of undeclared sibutramine. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

Sibutramine is a pharmaceutical ingredient that requires FDA approval. The unapproved marketing and undeclared presence of this ingredient makes the product a Class I drug recall. All lots within expiry are affected.

The product, identified by UPC 8 936188 880108 and sold by eBay seller John Nguyen, was distributed nationwide in the USA. Consumers who have purchased this product should stop using it immediately and consult a healthcare provider if they have questions about their health.

The recalled product

Product
Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 goi/sachets, MATXI CORP, UPC 8 936188 880108
Manufacturer
Ebay Seller - John Nguyen
Hazard
  • unapproved-drug
  • undeclared-sibutramine
  • cardiovascular-risk

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.