The agency also said it has received information showing that samples of Soladek contain unsafe levels of vitamins A and D.
An overdose of vitamins A or D can cause fatigue, headache, anemia, birth defects and other problems.
The FDA urged consumers who have Soladek to stop using it immediately and contact their doctor if they are experiencing symptoms.
Soladek is marketed by Indo Pharma S.A., a company based in the Dominican Republic. The solution comes in a vial and is labeled in Spanish.
The FDA said the product violates U.S. law because it claims to treat various medical conditions, including rickets and infection, but has not undergone regulatory review.
The FDA requires products claiming to treat disease to be proven safe and effective before they can be marketed.