54-10
Bulk/Finished Dietary Supplements Products Containing Aristolochic Acid
1 firm from 1 country is named on this alert. Their shipments may be detained at the port without physical examination. The oldest listing here dates to 18 September 2009.
- 1firm listed
- 1country
- 23 March 2026alert last published
- Source on FDA →accessdata.fda.gov
Why FDA issued it
The botanical Aristolochia spp. and other plants in the Aristolochiaceae family are widely used as ingredients in traditional Chinese herbal medicines and other traditional medicines. These products may often be labeled for drug use (e.g., claims that they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases), although there are no approved new drug applications (NDAs). Some products containing botanicals in this family may also be labeled as dietary supplements or may not be labeled in accordance with the requirements for any specific FDA-regulated product. Plants in the Aristolochiaceae family contain aristolochic acid, which is a substance known to result in serious adverse health effects when taken orally by humans or animals. Several outbreaks of renal failure in recent years have been attributed to the use of Chinese herbal medicines that we
Quoted from the “Reason for Alert” section of the FDA page for 54-10, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.
Firms named on 54-10
| Firm | Country | Listed since | |
|---|---|---|---|
| Kaiser Pharmaceutical Co.No. 9 Huangong Rd. , Yongkang Dist. , Tainan City, TAIWAN | Taiwan | 18 Sep 200916 yr |