Adverse Events and Recalls

FDA’s Drug Safety Priorities for 2023

February 21, 2024

FDA's Drug Safety Priorities FY23 describes the center’s key safety programs and activities involved in promoting and protecting public health.

EMA Issues Reminder Over Paxlovid Risks

February 12, 2024

The agency’s safety committee stressed the risk of potential adverse reactions involved with taking Paxlovid (nirmatrelvir, ritonavir) in combination with certain immunosuppressants.

Azurity Recalls Zenzedi

January 29, 2024

The company issued the recall because of a package mislabeling problem.

EMA Starts Safety Review of CAR T-Cell Medicines

January 17, 2024

The agency is reviewing data on secondary malignancies related to T-cells for approved CAR T-cell medicines.

Precautionary Measures Recommended in Use of Valproate Medicines

January 15, 2024

The European Medicines Agency safety committee says there is a potential risk of neurodevelopment disorders in children born to men treated with valproate.

Leiters Health Recalls Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags

January 09, 2024

The potential for superpotent drug initiated the voluntary recall.

InvaGen Pharmaceuticals Recalls Vigabatrin for Oral Solution, USP 500 mg

December 11, 2023

The product is being voluntarily recalled because of powder leakage due to seal integrity issues.

Novartis Voluntarily Recalls Two Lots of Sandimmune Oral Solution, 100 mg/mL

December 04, 2023

Novartis has issued a nationwide voluntary recall of two lots of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL because of crystallization issues.

Sucralfate Oral Suspension Recalled Due to Microbial Contamination

September 25, 2023

VistaPharm is recalling Sucralfate Oral Suspension, 1g/10mL because of Bacillus cereus contamination.

FDA Warns that Tydemy May Have Reduced Effectiveness

August 08, 2023

Lower levels of an active ingredient may result in unexpected pregnancies.