Maple syrup urine disease, a disorder of branched-chain amino acid catabolism that results in abnormal accumulations of the amino acids and their metabolites, was suspected in a healthy infant born to a mother who ingested a paste prepared from fenugreek seeds early in labor. 30 Fenugreek, maple syrup, and the urine of patients with the disease share a characteristic odor originating from a common ingredient, sotolone. The seeds have been used in traditional medicine to augment milk supply in nursing women. The extent of transmission of fenugreek-derived constituents into breast milk is unknown.
In July 2011, FDA began a pilot program to notify people of drug recalls before they are classified in an effort to expedite notifications of human drug product recalls to the public. FDA is now able to accomplish the goal of expedited notification within the Enforcement Report. These recalls are identified within the Enforcement Report by the label of “Not Yet Classified” in the “Classification” column. It is also possible to search the Enforcement Report for these “Not Yet Classified” recalls using the filter drop down menu. Therefore, as of September 15, 2017 FDA will discontinue the pilot program, and will no longer post drug recalls that are pending classification on this webpage. To see posted recalls that are pending classification go to the weekly Enforcement Report.