FDA Alerts Archive for 2024

January 5, 2024

• Leiters Health Issues Voluntary Nationwide Recall of Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags Due to Potential for Superpotent Drug

January 11, 2024

• Drug Safety Communication: Certain Type of Medicines Approved for Type 2 Diabetes and Obesity - Update on FDA’s Ongoing Evaluation of Reports of Suicidal Thoughts or Actions

January 19, 2024

• Kilitch Healthcare India Limited Issues Amendments in Last Voluntary Nationwide Recall Press Release
• Drug Safety Communication: Prolia (denosumab) - FDA Adds Boxed Warning for Increased Risk of Severe Hypocalcemia in Patients with Advanced Chronic Kidney Disease

January 23, 2024

• Update: FDA Warns Consumers Not to Purchase or Use Neptune’s Fix or Any Tianeptine Product Due to Serious Risks

January 24, 2024

• Haleon Issues Voluntary Nationwide Recall of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult Products Due to Microbial Contamination
• Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Zenzedi (dextroamphetamine sulfate tablets, USP) 30 mg Due to a Mislabeled Package During Manufacturing

January 28, 2024

• Neptune Resources, LLC Issues Voluntary Nationwide Recall of Neptune’s Fix

January 31, 2024

• FDA Warns Consumers of Contaminated Copycat Eye Drops

February 1, 2024

• Insight Pharmaceuticals Issues Voluntary Nationwide Recall of TING® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid Due to the Presence of Benzene

February 2, 2024

• Today The World Issues Voluntary Nationwide Recall of All Lots of Arize Herbal Dietary Supplement Capsules Due to the Presence of Undeclared Nortadalafil
• Today The World Issues Voluntary Nationwide Recall of All Lots of Sustain and Schwinnng brand Dietary Supplement Capsules Due to the Presence of Undeclared Tadalafil and Nortadalafil

February 6, 2024

• FDA Safety Communication: Recall of Certain Saline and Sterile Water Medical Products Associated with Nurse Assist

February 17, 2024

• Nordic Naturals Issues Voluntary Recall of Baby's Vitamin D3 Liquid Due to Elevated Levels of Vitamin D3

February 22, 2024

• Brassica Pharma Pvt. Ltd. Issues Voluntary Nationwide Recall of Eye Ointment Products Due to Potential Lack of Sterility

March 12, 2024

• Par Pharmaceutical Issues Voluntary Nationwide Recall of One Lot of Treprostinil Injection Due to Potential for Silicone Particulates

March 19, 2024

• Pyramid Wholesale Issues Recall of Various Brands of Products Sold as Dietary Supplements for Sexual Enhancement

March 26, 2024

• FDA Warns Consumers to Avoid Certain Topical Pain Relief Products Due to Potential for Dangerous Health Effects

March 27, 2024

• Amneal Issues a Nationwide Voluntary Recall of Vancomycin Hydrochloride for Oral Solution USP, 250mg/5mL Due to the Potential for Some Bottles to be Super Potent

March 28, 2024

• Eugia US LLC Issues Voluntary Nationwide Recall of Methocarbamol Injection, USP 1000 mg/10 mL Due to Presence of White Particles

March 29, 2024

• AvKARE, LLC. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750 mg/5 mL Due to Potential Bacillus Cereus Contamination

April 2, 2024

• ForeverMen Supplements Recalled

April 5, 2024

• Aruba Aloe Balm N.V. Issues Voluntary Nationwide Recall of Aruba Aloe Hand Sanitizer Gel Alcohol 80% and Aruba Aloe Alcoholada Gel Due to Presence of Methanol

April 9, 2024

• Otsuka Initiates Voluntary Nationwide Recall of Certain Lots of Abilify (aripiprazole) Tablets Due to Drug Product Cross-Contamination on Manufacturing Equipment

April 16, 2024

• Counterfeit Versions of Botox Found in Multiple States

April 18, 2024

• FDA Requires Boxed Warning for T Cell Malignancies Following Treatment with BCMA-Directed or CD19-Directed Autologous CAR T Cell Immunotherapies

April 22, 2024

• Stop Clopez Corp. Issues Voluntary Worldwide Recall of Schwinnng Capsules Due to the Presence of Undeclared Nortadalafil

April 23, 2024

• Dr. Reddy’s Issues Voluntary Nationwide Recall of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg Due to Sub-Potency

April 29, 2024

• FDA Alerts Health Care Professionals of Pregnancy Problems Associated with Thiopurines

May 13, 2024

• FDA Safety Communication: Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results

May 16, 2024

• Cross-Compatibility Issues with Autoinjector Devices Optional for Use with Glatiramer Acetate Injection

May 21, 2024

• Hospira Inc. Issues Voluntary Recall for Buprenorphine HCl Injection Carpuject Units and Labetalol HCl Injection Carpuject Units Due to Potential for Incomplete Crimp Seals

May 28, 2024

• Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Docetaxel Injection, USP Due to Potential Presence of Particulate Matter

June 6, 2024

• HomeoCare Laboratories Inc. Issues Recall of Stella Life Oral Care Spray Unflavored and Advanced Formula Peppermint Oral Care Rinse Due to Microbial Contamination

June 11, 2024

• Penn Herb Company Ltd Recalls Nature’s Wonderland Thyroid Formula Because of Possible Health Risk
• Male Enhancement Supplements Recalled

June 24, 2024

• Glenmark Pharmaceuticals Inc., USA Issues Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due to Failed Dissolution

June 25, 2024

• American Health Packaging on Behalf of BluePoint Laboratories Issues Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due to Failed Dissolution

June 26, 2024

• Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies Modified to Minimize Burden on Healthcare Delivery System

July 12, 2024

• Supercore Issues Voluntary Worldwide Recall of Hard Steel Capsules & Gold Hard Steel Plus Liquid Due to the Presence of Sildenafil and Acetaminophen

July 16, 2024

• FDA, FTC Continue Joint Effort to Protect Consumers Against Companies Illegally Selling Copycat Delta-8 THC Food Products
• GURU INC. Issues Voluntary Nationwide Recall of Infla-650 Herbal Dietary Supplement Capsules Due to Hidden Drug Ingredients
• Endo USA, Inc. Issues Recall of One Lot of Clonazepam Orally Disintegrating Tablets Due to Mislabeling: Incorrect Strength on Product Carton

July 18, 2024

• Aurobindo Pharma USA, Inc. on Behalf of AuroHealth, Issues Recall of One Lot of Healthy Living Over the Counter (OTC) Migraine Relief

July 22, 2024

• Hikma Pharmaceuticals USA Inc. Extends Voluntary Nationwide Recall of One Lot of Acetaminophen Injection, 1000mg/100mL (10mg/mL) Bags
• Main Products, Inc. Issues Recall of Umary Acido Hialuronico, Suplemento Alimenticio Due to the Presence of Undeclared Drug Ingredients

July 30, 2024

• FDA Warns Against Purchasing or Using Chemical Peel Skin Products Without Professional Supervision

August 5, 2024

• Baxter Issues Voluntary Nationwide Recall of One Lot of Heparin Sodium in 0.9% Sodium Chloride Injection Due to Potential for Elevated Endotoxin Levels

August 6, 2024

• FDA Warns Consumers to Not Purchase or Use Unapproved Inhalant Products Marketed for Alertness and Energy Boosting

August 8, 2024

• B. Braun Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride for Injection USP 1000 mL in E3 Containers Due to the Potential for Particulate Matter and Leakage

August 14, 2024

• Boulla LLC Issues Voluntary Nationwide Recall of Boom Max Capsules Due to the Potential Presence of Undeclared Sildenafil
• Veata LLC Issues Voluntary Nationwide Recall of Endurance Pro Capsules Due to the Potential Presence of Undeclared Sildenafil

September 5, 2024

• FDA Warns Consumers Not to Purchase or Use Umary and Amazy Products As They May Be Harmful To Your Health

September 12, 2024

• Drug Safety Communication: FDA Adds Warning About Rare Occurrence of Serious Liver Injury with Use of Veozah (fezolinetant) for Hot Flashes Due to Menopause

September 17, 2024

• Bionpharma Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension Due to Bacterial Contamination

September 18, 2024

• FDA Warns Consumers Not to Use SnoreStop Nasal Spray by Green Pharmaceuticals Due to Potential Contamination

September 20, 2024

• Gilead Issues Voluntary Nationwide Recall of One Lot of Veklury (Remdesivir) for Injection 100 mg/vial Due to the Presence of a Glass Particle

September 26, 2024

• FDA is Alerting Patients and Health Care Professionals About the Voluntary Withdrawal of Oxbryta from the Market Due to Safety Concerns

October 2, 2024

• FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize

October 16, 2024

• Staska Pharmaceuticals, Inc. Issues Recall of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL Due to the Presence of Glass Particles
• C&A Naturistics Issues Voluntary Nationwide Recall of AK Forte Tablets con Ortiga y Omega 3 Due to the Presence of Undeclared Drug Ingredients

October 17, 2024

• Public Safety Notification on Amniotic Fluid Eyedrops

October 30, 2024

• Do Not Purchase or Use Skin-Cap Aerosol Spray Products Because They May Be Harmful to Your Health

November 1, 2024

• FDA Warns Patients and Health Care Professionals Not to Use Compounded Drugs from Fullerton Wellness

November 4, 2024

• Boulla LLC Issues Voluntary Nationwide Recall of ZoomMax and ZapMax Capsules Due to the Presence of Undeclared Sildenafil and Diclofenac
• VitalityVita Issues Voluntary Nationwide Recall of VitalityXtra and PeakMax Capsules Due to the Presence of Undeclared Sildenafil and Diclofenac

November 19, 2024

• Endo Expands Voluntary Recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Due to Potential Product Carton Strength Mislabeling

November 20, 2024

• Mxbbb Issues Voluntary Nationwide Recall of Umary Acid Hyaluronic Due to the Presence of Diclofenac and Omeprazole

November 27, 2024

• FDA Investigating Serious Risk of Hematologic Malignancy Following Skysona (elivaldogene autotemcel)

December 12, 2024

• Buy-herbal.com Issues Voluntary Nationwide Recall of Nhan Sam Tuyet Lien Truy Phong Hoan Capsules Due to Undeclared Furosemide, Dexamethasone and Chlorpheniramine
• GNMART INC Issues Voluntary Nationwide Recall of Force Forever Due to Undeclared Drug Ingredients Diclofenac and Dexamethasone
• Drug Safety Communication: Ocaliva (obeticholic acid) - Serious Liver Injury Being Observed in Patients without Cirrhosis

December 16, 2024

• FDA Adds Boxed Warning to Veozah (fezolinetant) to Highlight the Known Risk of Rare But Serious Liver Injury
• Shoppers-Plaza Issues Voluntary Nationwide Recall of Fouzee Sugarlin Herbal Formula Due To Presence Of Undeclared Metformin And Glyburide

December 20, 2024

• Endo USA, Inc. Issues Voluntary, Nationwide Recall of Adrenalin® Chloride Solution (EPINEPHrine Nasal Solution, USP) Due to the Potential for Administration Errors

December 21, 2024

• Alcon Laboratories Issues Voluntary Nationwide Recall of One Lot of Systane Lubricant Eye Drops Ultra PF Due to Fungal Contamination

December 23, 2024

• Astellas Issues Recall of One Lot of Prograf 0.5 mg and One Lot of Astagraf XL 0.5 mg Because Bottles Shipped to U.S. May Contain Empty Capsules