The FDA is investigating reports of at least 775 serious side effects from drugs recalled by McNeil, some of which included death.
The report says the FDA is looking into seven deaths since the May 1 recall of several children's medicines, but no positive links have been made.
Those medicines were made at McNeil's plant in Fort Washington. McNeil is a division of Johnson & Johnson.
But they also say they are investigating quote "adverse events" that do appear to be related to the recall.
Adverse event reports are consumer complaints of a serious side effect associated with the use of a medical product.
Congress will start looking into this with a hearing set for Thursday.