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.
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 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…
- Manufacturer
- Qikmoov LLC
- Category
- Drug — Herbal/Dietary supplement
- Affected units
- 591
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.
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