The Recall Desk
Agency classClass IOur severity:CriticalFDA (Food)·F-1817-2017·Announced 2017-04-05

Baidyanath Gaisantak Bati Recalled for Heavy Metal Contamination

Butala Emporium, Inc. is recalling Baidyanath brand Gaisantak Bati dietary supplements because they contain lead, mercury, and/or arsenic at levels 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 indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The presence of heavy metals like lead, mercury, and arsenic at excessive levels is a severe health hazard.

Plain-English summary

Butala Emporium, Inc. is recalling Baidyanath brand Gaisantak Bati, a dietary supplement manufactured in India by Shree Baidyanath Ayurved Bhawan (P) Ltd. The recall involves 618 bottles of the product, specifically Batch No. GAI-09 with an expiry date of 08/2018 and Batch No. 141 with an expiry date of 10/2017.

The FDA issued this recall because the dietary supplements were found to contain lead, mercury, and/or arsenic at levels exceeding permissible limits. These heavy metals are toxic substances that can cause serious health problems when ingested.

The product was distributed in 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 have purchased this product should stop using it and contact the recalling firm for instructions on how to return it or obtain a refund.

The recalled product

Product
Baidyanath brand Gaisantak Bati, Dietary Supplement, 80 Tablets -- Product of India --- Mfd in India - Shree Baidyanath Ayurved Bhawan (P) Ltd. 1 Gupta Lane, Kolkata 700006
Manufacturer
Butala Emporium, Inc.
Category
Food — Dietary Supplement
Hazard
Affected units
618

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. 1) GAI-09 & 2) 141
  • Expiry Date 1) 08/2018 & 2) 10/2017

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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