The Recall Desk
Agency classClass IOur severity:CriticalFDA (Food)·F-1811-2017·Announced 2017-04-05

Baidyanath Saptamrit Lauh Recalled for Heavy Metal Contamination

Butala Emporium is recalling Baidyanath Saptamrit Lauh dietary supplements found to contain lead, mercury, and/or arsenic exceeding permissible limits.

The agency’s classification

FDA (Food): 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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. 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 per the rubric, indicating a reasonable probability of serious adverse health consequences.

Plain-English summary

Butala Emporium, Inc. is recalling Baidyanath brand Saptamrit Lauh dietary supplements, 80 tablets. The product is manufactured in India by Shree Baidyanath Ayurved Bhawan (P) Ltd. The recall is due to the presence of lead, mercury, and/or arsenic at levels exceeding permissible limits.

The affected product is identified by Batch No. SPL-04 with an expiry date of 4/2018. Distribution was limited to New York via three retail stores and directly to 26 individual consumers in Connecticut, Florida, Hawaii, New Jersey, Pennsylvania, Ohio, Massachusetts, the District of Columbia, Vermont, and Puerto Rico.

Consumers who purchased this product should stop using it and contact Butala Emporium, Inc. for a refund or further instructions. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

The recalled product

Product
Baidyanath brand Saptamrit Lauh, Dietary Supplement, 80 Tablets -- Product of India --- Mfd in India - Shree Baidyanath Ayurved Bhawan (P) Ltd. 1 Gupta Lane, Kolkata 700006

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 (2)

  • Batch No. SPL-04
  • Expiry Date 4/2018

Distribution

Distributed in 10 states:

Part of a larger recall action

This product is one of 10 recalled by Butala Emporium, Inc. under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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