FDA Alerts
2026
MC26-001-CG FDA request removal suicidal ideation and behavior warning from label glucagon-like peptide-1 MC26-002-CG FDA - Abbott Initiates Medical Device Correction for FreeStyle Libre 3 and Libre 3 Plus Sensors MC26-003-CG FDA - Trividia initiate labeling correction for all TRUE METRIX Blood Glucose Monitoring MC26-004-CG FDA update labeling of capecitabine and fluorouracil (5-FU) risk associate DPD deficiency MC26-005-CG FDA Warning about Vitamin B6 Deficiency and Associated Seizures for Drug Products MC26-006-CG FDA – CDRH Early Alert Insulin Pump Issue from Insulet - Affected devices Omnipod 5 Pods MC26-007-CG FDA Identifies Cases of Serious Liver Injury in Patients Taking Tavneos (avacopan) MC26-009-CG FDA Cardinal recall Webcol Large Alcohol Prep Pads due to microbial contamination MC26-010-CG FDA Insulin Pump Correction Tandem Diabetes Care Issues Correction for Tandem Mobi Insulin Pumps MC26-011-CG Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health MC26-012-CG FDA Insulin Pump Recall - Insulet Removes Certain Omnipod 5 Pods MC26-014-CG FDA Labeling Changes OTC Weight Loss Drug Alli (Orlistat) to Warn Risk Kidney Stones MC26-016-CG FDA - Unique Pharmaceuticals recall 4 lots of Cetirizine Hydrochloride Tabs USP 5 mg MC26-018-CG FDA - Fresenius Kabi recall 1 lot Tyenne (tocilizumab-aazg) Injection 400 mg 20 mL MC26-019-CG FDA - Vitruvias recall 1 lot Thyroid Tablets USP 30 mg
2025
MC25-001-CG FDA Astellas recall 1 lot PROGRAF 0.5mg and 1 of ASTAGRAF XL 0.5mg capsules MC25-005-CG FDA - Requires Guillain-Barré Warning in Prescribing Info for RSV Vaccines Abrysvo and Arexvy MC25-006-CG Copaxone, Glatopa FDA Adds Boxed Warning About Serious Allergic Reaction Called Anaphylaxis MC25-007-CG FDA Alvogen recalling 1 lot Fentanyl Transdermal System 25 mcgh transdermal patches MC25-011-CG FDA warns about allergy medicines cetirizine or levocetirizine long-term use may cause itching MC25-012-CG FDA Amneal recall 3 lots of Sulfamethoxazole Trimethoprim Tablets USP 400 mg 80 mg MC25-013-CG FDA Warning About Risk of Heat-Related Complications with Antinausea Patch Transderm Scōp MC25-014-CG FDA Require Expand Label Weight Loss Patients Younger than 6 yrs taking ER Stimulants for ADHD MC25-017-CG FDA - CBER suspended biologics license for Valneva Austria GmbH’s Ixchiq (Chikungunya Vaccine) MC25-018-CG FDA recommend earlier MRI for patients with Alzheimer disease taking Leqembi (lecanemab) MC25-019-CG FDA Removes Risk Evaluation Mitigation Strategies Program for Antipsychotic Drug Clozapine MC25-020-CG FDA Nostrum recall Sucralfate Tablets USP 1 gram all lots within expiry MC25-021-CG FDA Unichem recalling 1 lot Cyclobenzaprine Hydrochloride Tabs USP 10 mg due to Mislabeling MC25-023-CG FDA Nationwide recall atorvastatin calcium tablets 10, 20, 40, 80 milligram doses MC25-024-CG FDA Early Alert Glucose Monitor Sensor - FreeStyle Libre 3 Several Models from Abbott (1) MC25-025-CG Update on the Safety of Andexxa by AstraZeneca FDA Safety Communication