The FDA has issued two warning letters to Bayer for not submitting proof that the Bayer Women’s Low Dose Aspirin + Calcium and Bayer Aspirin With Health Advantage are useful in fighting heart disease and osteoporosis in women.
"These are not FDA-approved products," agency spokeswoman Rita Chappelle said. "They are selling products that are illegal."
The FDA has given a warning to Bayer to remove the medicines from the shelves or else face legal action.
But Bayer defended the medications and its right to market them.
"We stand behind both products and all marketing claims made in their support," the German drugmaker said in a statement.