FDA Alerts Archive for 2025

January 7, 2025

• FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy

January 16, 2025

• FDA Warns Health Care Professionals Not to Use Epinephrine Nasal Solutions from BPI Labs and Endo USA

January 22, 2025

• Drug Safety Communication: Copaxone, Glatopa (glatiramer acetate) - FDA Adds Boxed Warning About a Rare but Serious Allergic Reaction Called Anaphylaxis

January 24, 2025

• Provepharm Inc. Issues Recall of One Lot of Phenylephrine Hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) Due to Presence of Particulate Matter
• Safety Announcement: FDA Highlights Importance of DPD Deficiency Discussions with Patients Prior to Capecitabine or 5FU Treatment

January 31, 2025

• Alvogen Issues Voluntary Nationwide Recall for One Lot of Fentanyl Transdermal System 25 mcg/h Due to a Defective Delivery System

February 13, 2025

• ICU Medical Issues Nationwide Recall of Potassium Chloride Injection, 20 mEq and Potassium Chloride Injection, 10 mEq Due to Mislabeling

February 24, 2025

• CAPS Issues Recall of Phenylephrine 40 mg Added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags Due to Visible Black Particulate Matter in a Single-Sealed Vial

February 25, 2025

• Natural Dior LLC Issues Voluntary Nationwide Recall of Vitafer-L Gold Liquid Due to Presence of Undeclared Tadalafil

March 3, 2025

• One Source Nutrition, Inc. Issues Voluntary Nationwide Recall of Vitality Capsules Due to Presence of Undeclared Sildenafil and Tadalafil

March 10, 2025

• Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) Due to Increased Reports of Allergic/Hypersensitivity Reactions

March 11, 2025

• Limited Number of Voluntary Recalls Initiated after FDA Testing of Acne Products for Benzene

March 13, 2025

• Dr. Reddy’s Issues a Nationwide Recall of Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL, in the U.S., Due to Mislabeling of Infusion Bag

March 14, 2025

• FDA Advises Consumers Not to Inhale Nitrous Oxide Products

April 14, 2025

• FDA Warns Consumers Not to Use Counterfeit Ozempic (semaglutide) Found in U.S. Drug Supply Chain

April 18, 2025

• Amneal Pharmaceutical LLC Issues a Nationwide Recall of Ropivacaine Hydrochloride Injection, USP 500mg/100mL, Due to the Potential Presence of Particulate Matter

April 22, 2025

• FDA Alerts Health Care Providers, Compounders and Consumers of Potential Risks Associated with Compounded Topical Finasteride Products

April 25, 2025

• Health Fixer Issues Voluntary Nationwide Recall of Male Ultra, Malextra, Electro Buzz, Ultra Armor and Male Ultra Pro

May 6, 2025

• Voluntary Nationwide Recall: Endurance Boost With Horny Goat Weed Capsules Due To Presence of Undeclared Propoxyphenylsildenafil and Sildenafil

May 9, 2025

• FDA and CDC Recommend Pause in Use of Ixchiq (Chikungunya Vaccine, Live) in Individuals 60 Years of Age and Older While Postmarketing Safety Reports are Investigated

May 16, 2025

• FDA Drug Safety Communication: FDA Requires Warning About the Risk of Pruritus After Stopping Long-Term Use of Cetirizine or Levocetirizine