The FDA hit Chinese drugmaker Shandong Vianor Biotech with a warning letter and placed the company on an import alert.

The FDA has issued a scathing warning letter to a Pfizer unit that produced EpiPens that failed during emergencies, some of them fatal.

Hospira issued a voluntary recall of one lot of hydromorphone and four lots of Levophed due to the potential of a lack of sterility.

Last month, following deaths in two Keytruda trials, the FDA halted the pair of Merck studies. And now, it’s warning the public about what’s at stake.

A generics maker in the U.K. had its manufacturing certification pulled after regulators found data-reporting issues.

The FDA has classified the ongoing recall by drug wholesaler Truxton of 18 lots of phenobarbital and amitriptyline tablets as Class I and Class II recalls.…

The FDA slapped Foshan Flying Medical with a warning letter for inadequate testing, validation and training issues at its plant in Guangdong, China.

The FDA bit into homeopathic pharmaceutical manufacturer Homeolab USA over belladonna-treated teething products that CVS took off the shelf last year.

Drug Safety