Eleven Ayurvedic Dietary Supplements Recalled for Excess Lead and Mercury

Butala Emporium, Inc. of Jackson Heights, New York has announced a voluntary recall of 11 Ayurvedic (dietary) supplements that were found to contain elevated lead and mercury levels.

These elevated lead and mercury levels may cause health problems, particularly in infants, small children, pregnant women, and those with underlying kidney disorders, the Food and Drug Administration (FDA) warns.

The concentration of lead exceeds the recommended daily lead exposure for children less than six years of age and for women of childbearing age and this lead level would likely be injurious to health. If a child or a pregnant woman is exposed to lead for a prolonged period—weeks to months—permanent damage to the central nervous system, learning disorders, developmental defects, and other long-term health problems can occur. The type and severity of such problems depends on the duration and degree of exposure.

The mercury levels in these products exceed safe weekly exposure and would likely be injurious to health. The elevated mercury levels in these products with short-term use can cause kidney, stomach, and intestinal symptoms. Exposure of a month or more could potentially be lethal. Mercury consumption at the level in these products can also cause psychiatric and personality disturbances, ataxia (or loss of coordination), visual loss, hearing loss, and other neurological conditions particularly to children exposed in utero. Butala is notifying individuals not to consume these products.

The following Baidyanath brand supplements are included in the recall:

Saptamrit Lauh, Batch No. SPL-04, Expiry date 4/2018                                                       Rajahpravartini Bati, Batch No. RAJ-15 0 & 126, Expiry Date 1/2019 & 07/2016
Sarivadi Bati, Batch No. SRI-09, Expiry Date 04/2018
Shankh Bati, Batch No. SHN-02, Expiry Date 08/2018
Marichyadi Bati, Batch No. 200, Expiry Date 08/2017                                                                   Agnitundi Bati, Batch No. 018, Expiry Date 02/2016
Arogyavardhini Bati, Batch No. 018, Expiry Date 03/2017
Sarivadi Bati, Batch No. SARI-015, Expiry Date 01/2019
Brahmi Bati, Batch No. HGB-18, Expiry Date 03/2019, Batch Nos. 244 & 242, Expiry Date 03/2017 (products without Batch No. or Expiry Date are subject to this recall)
Gaisantak Bati, Batch No. GAI-09, Expiry Date 08/2018 and Batch No. 141, Expiry Date 10/2017
Chitrakadi Bati, Batch No. 193, Expiry Date 02/2018

The 80-count capsules come in white, plastic bottles with green, yellow or orange labeling under the brand name Baidyanath made by Shree Baidyanath Ayurved Bhawan Ltd., Kolkata, India. A top cap sticker says the product is imported by Butala Emporium.

The products were distributed in New York through retail stores and sold online in California, Connecticut, Florida, Hawaii, Massachusetts, New Jersey, Ohio, Pennsylvania, Vermont, Washington D.C., and Puerto Rico. No complaints of illnesses have been received to date.

The high levels of lead and mercury were discovered during testing by the New York City Department of Health and the FDA.

Consumers who have purchased these products are urged not to consume them and should return them to the place of purchase for a full refund.  Consumers may contact Butala at 1-718-899-5590, Monday – Friday, 9 am – 5 pm ET, or email butala1@aol.com.

Adverse reactions or quality problems experienced with these products may be reported to the FDA’s MedWatch Adverse Event Reporting program: www.fda.gov/medwatch/report.htm.

 

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