FDA’s Actions to Address Unapproved Thyroid Medications

The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.

Unapproved New Drugs/Misbranded

CGMP/Finished Pharmaceuticals/Adulterated

Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey (Amneal), is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the Consumer Level. Some bottles may have been overfilled which can res

Salinas, Calif., August 26, 2025 – In response to a recall initiated by Latitude 36 Foods, LLC., Taylor Fresh Foods is voluntarily recalling the Taylor Farms Honey Balsamic Salad Kit 6/8.3oz. because it may contain undeclared sesame and soy allergens. People who have an allergy or severe sensitivity

CENTER VALLEY, Pa., (October 31, 2025) – Olympus Corporation has announced a voluntary, global medical device corrective action to provide further clarification on the safe and effective use of bronchoscopes with laser therapy, argon plasma coagulation or high-frequency cauterization equipment durin