The drug product(s) included in any of the potential signals of serious risks/new safety information listed below may also include the generic version of the drug […]

Addyi (flibanserin) Accidental exposure to product by child FDA decided that no action is necessary at this time based on available information. Betadine (povidone-iodine) E-Z Prep […]

Articaine hydrochloride (HCl)/epinephrine bitartrate injection Orabloc (articaine HCl/epinephrine bitartrate) injection Septocaine (articaine HCl/epinephrine bitartrate) injection, solution Paresthesia and taste disturbances FDA has determined that the last […]

Introduction | Phase 1 | Phase 2  Introduction This content provides more detailed information for the FDA PreCheck Pilot Program.  The FDA PreCheck Pilot Program seeks […]

Date: May 5 – 6, 2026 Day1: Tue, May 05 8:30 a.m. – 05:30 p.m. ET Day2: Wed, May 06 8:30 a.m. – 04:30 p.m. ET […]

We review information on impurity testing provided in drug applications and when inspecting manufacturing facilities. Manufacturers are required to test for impurities that may be introduced […]

Frequently Asked Questions Q. Why did FDA withdraw approval of Makena and its generics? A. Makena and its generics (i.e., generic versions of Makena) are not […]

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Bridget M. Goddard Recipient Title Manager Pure Indulgence Aesthetics 1695 East Southlake Boulevard Suite 150Southlake, TX 76092United […]

Summary Company Announcement Date: April 08, 2026 FDA Publish Date: April 08, 2026 Product Type: Drugs Reason for Announcement: Recall Reason Description Products were found to […]