O in all probability was recalled because of issues related to administration and or specific responses to substrates certain individuals respond to.
FDA approved the drug based on the efficacy and safety of the drug. Even then ( which IMHO is not the case), FDA cannot be sued until it is found that FDA overlooked some facts or details.
If anybody, it is the lab who stands the most chance of getting sued and that' s exactly the modalities being worked out in the background ( look for maxdads
posts on these in the past)