The Recall Desk
CriticalFDA (Drugs)·D-0296-2016·Announced 2015-11-25

LiDa DAIDAIHUA capsules recalled for undeclared sibutramine and phenolphthalein

Blue Square Market, Inc. is recalling LiDa DAIDAIHUA capsules nationwide because they contain undeclared sibutramine and phenolphthalein and were marketed without an approved NDA or ANDA.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Blue Square Market, Inc. is recalling LiDa DAIDAIHUA (also packaged as LiDa DAIDAIHUAJIAONANG) capsules. The product is packaged in 1.6oz boxes containing 30 capsules each. The recall covers 25 boxes and all lots of the product.

The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product contains undeclared sibutramine and phenolphthalein. The product was distributed nationwide.

Consumers who have purchased this product should stop using it immediately. They should return the product to the place of purchase for a refund or contact the recalling firm for further instructions.

The recalled product

Product
LiDa DAIDAIHUA (also packaged as LiDa DAIDAIHUAJIAONANG), capsules, packaged in 1.6oz box 30 capsules per box, Kunming Dali Industry & Trade Co., Ltd
Affected units
25

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.

Part of a larger recall action

This product is one of 2 recalled by Blue Square Market, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Blue Square Market, Inc.

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