The Recall Desk
SevereFDA (Drugs)·D-0749-2021·Announced 2021-08-11

Vy&Tea herbal tea recalled for unapproved drug ingredient sibutramine

Qikmoov LLC is recalling Vy&Tea herbal tea because FDA analysis detected sibutramine, an ingredient not approved in an NDA or ANDA application. The product was marketed and distributed nationwide and internationally.

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 classified this as a Class I recall. Under the severity rubric, FDA Class I recalls without reported deaths are scored as 4 (Severe), as the agency's own classification mandates a minimum score of 4.

Plain-English summary

Qikmoov LLC is recalling Vy&Tea herbal tea (15 sachets per box, 45.0G) because FDA analysis found the presence of sibutramine, a drug ingredient that requires approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) before marketing in the United States. The product was marketed without such approval.

The recalled product was distributed nationwide in the USA via the internet and to Brazil, Canada, Germany, France, Hong Kong, Italy, Sweden, Switzerland, Thailand, and the United Kingdom. Affected boxes have a Best By Date of 9/2021 and were manufactured by Havyco in Vietnam.

Consumers who have purchased this product should stop use immediately. The presence of sibutramine—a prescription drug ingredient—in an unapproved herbal tea product poses a safety risk.

The recalled product

Product
Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 45.0G (15 tea sachets per box), Manufactured by Havyco No. 45, Group 1, National Highway 14, Son Hiep Hamlet, Tho Son Commune, Bu Dang District, Binh Phuoc Province, Vietnam, Website: trathaomocgiamcan.co
Manufacturer
Qikmoov LLC
Hazard
  • unapproved-drug-ingredient
  • sibutramine

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)

  • Best By Date: 9/2021

Distribution

Distributed nationwide across the United States.