How do I report a problem or illness caused by an infant formula?

If a consumer has a general complaint or concern about a food product including an infant formula, FDA is the appropriate agency to contact. These problems, complaints, or injuries can be reported in writing or by telephone, or by the Internet at http://www.fda.gov/opacom/backgrounders/problem.html

If you think your infant has suffered a serious harmful effect or illness from an infant formula, your health care provider can report this by calling FDA's MedWatch hotline at 1-800-FDA-1088 or by using the website www.fda/report/hcp.htm. The MedWatch program allows health care providers to report problems possibly caused by FDA-regulated products such as drugs, medical devices, medical foods, dietary supplements, and infant formulas. The identity of the patient is kept confidential. In addition, health care providers should report infectious diseases in infants associated with use of infant formula to CDC's Division of Healthcare Quality Promotion (1-800-893-0485).

Consumers may also report an illness, injury or other problem they believe to be related to the use of an infant formula by calling FDA at 1-800-FDA-1088 or using the website www.fda.gov/medwatch/report/consumer/consumer.htm. FDA would like to know when a product may have caused a problem even if you are unsure the product caused the problem or even if you and the baby do not visit a doctor or clinic.

Infant formula manufacturers provide toll-free telephone numbers on the labels of their products and should be notified about problems, complaints, or injuries caused by their products.