FDA Alerts Archive for 2023

January 9, 2023

• Spectrum Laboratory Products, Inc. Issues Voluntary Worldwide Recall of Epinephrine (L-Adrenaline) USP Bulk Active Pharmaceutical Ingredient (API) Due to Discoloration of Product

January 27, 2023

• Edgewell Personal Care Issues Voluntary Nationwide Recall of Banana Boat Hair & Scalp Sunscreen Due to the Presence of Benzene – UPDATED

February 1, 2023

• IBSA Pharma Inc. Issues Voluntary Nationwide Recall of Select Lots of Tirosint®-Sol (levothyroxine sodium) Oral Solution Due to Subpotency

February 2, 2023

• FDA Warns Consumers Not to Purchase or Use EzriCare Artificial Tears Due to Potential Contamination

February 8, 2023

• Public Notification: Alfia Weight Loss Capsules Contain Hidden Drug Ingredient

February 9, 2023

• Infants at Risk for Aluminum Toxicity with Unapproved Potassium Phosphates Drug Product

February 13, 2023

• Volt Candy Issues Voluntary Nationwide Recall of PrimeZen Black 6000 Capsules Due to Presence of Sildenafil and Tadalafil

February 14, 2023

• nanoMaterials Discovery Corporation Issues Voluntary Nationwide Recall of its Alcohol Antiseptic 80% Alcohol Solution

February 23, 2023

• Global Pharma Healthcare Issues Voluntary Nationwide Recall of Delsam Pharma Artificial Eye Ointment Due to Possible Microbial Contamination

March 3, 2023

• Pharmedica USA LLC Issues Voluntary Worldwide Recall of Purely Soothing 15% MSM Drops Due to Non-Sterility

March 22, 2023

• Ascend Laboratories LLC. Issues Voluntary Nationwide Recall of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

March 31, 2023

• Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750mg/5mL Due to Potential Bacillus Cereus Contamination in the Product

April 10, 2023

• Public Safety Notification on Amniotic Fluid Eyedrops

April 13, 2023

• Drug Safety Communication: All Opioid Pain Medicines - FDA Updates Prescribing Information to Provide Additional Guidance for Safe Use

April 26, 2023

• Akorn Issues Voluntary Nationwide Recall of Various Human and Animal Drug Products Within Expiry Due to Company Shutdown

April 27, 2023

• TruVision Health Recalls Dietary Supplement Products Because of Possible Health Risk
• Teva Initiates Voluntary Nationwide Recall of Specific Lots of Fentanyl Buccal Tablets CII Due to a Labeling Error

May 1, 2023

• FDA Warns Consumers to Not Purchase or Use Nose Slap and Soul Slap Products Marketed for Alertness and Energy Boosting

May 4, 2023

• Family Dollar is Initiating a Voluntary Recall of Certain Over-the-Counter Drug Products Because the Products Have Been Stored Outside of Labeled Temperature Requirements

May 11, 2023

• FDA Updating Warnings to Improve Safe Use of Prescription Stimulants Used to Treat ADHD and Other Conditions

May 19, 2023

• Novis PR LLC Issues Voluntary Recall of G-Supress DX Pediatric Drops Due to Incorrect Packaging

May 31, 2023

• FDA Issues Warning About Compounded Medications Containing Semaglutide Marketed for Type 2 Diabetes or Weight Loss

June 13, 2023

• The Harvard Drug Group, LLC Issues Voluntary Nationwide Recall of Dronabinol Capsules USP 2.5 mg and Ziprasidone Hydrochloride Capsules 20 mg Due to Label Mix-Up

July 6, 2023

• Cipla Issues Voluntary Nationwide Recall of Six Batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) Due to Container Defect

July 28, 2023

• Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of 2 Lots of Tydemy Due to Out of Specification (OOS) Results at the 12-month Stability Time Point

August 22, 2023

• FDA Warns Consumers Not To Purchase or Use Certain Methylsulfonylmethane (MSM) Eye Drops Due to Contamination

August 26, 2023

• Dr. Berne’s Whole Health Products Issues Voluntary Nationwide Recall of Dr. Berne’s MSM Drops 5% and 15% Solution Eye Drops Due to Bacterial and Fungal Contamination

August 30, 2023

• Marlex Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Digoxin Tablets USP, 0.125mg and Digoxin Tablets USP, 0.25mg Due to Label Mix-Up

September 5, 2023

• WEFUN Inc. Issues Voluntary Nationwide Recall of WEFUN Capsules Due to Presence of Undeclared Sildenafil

September 8, 2023

• Church & Dwight Initiates Voluntary Recall of One Specific Lot of TheraBreath Kids Strawberry Splash 16oz Sold Exclusively on Amazon Between May 31 and September 02, 2023, Due to an Isolated Manufacturing Issue

September 11, 2023

• Novartis Issues Voluntary Nationwide Recall of One Lot of Sandimmune Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/mL Due to Crystallization

September 12, 2023

• FDA Issues Warning Letters to Firms Marketing Unapproved Eye Products

September 18, 2023

• FDA is Changing the Therapeutic Equivalence Rating for Accord Healthcare Inc.’s Generics of Prograf (tacrolimus) Oral Capsules

September 20, 2023

• Medline Industries Recalls Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution Due to Being Non-Sterile

September 22, 2023

• VistaPharm LLC Issues Voluntary Nationwide Recall of Sucralfate Oral Suspension, 1g/10mL Due to Microbial Contamination Identified as Bacillus Cereus

September 27, 2023

• Scynexis Issues a Voluntary Nationwide Recall of Brexafemme (ibrexafungerp tablets) Due to Potential for Cross Contamination with a Non-Antibacterial ßlactam Drug Substance

September 29, 2023

• Warning Regarding Use of Probiotics in Preterm Infants
• Biomic Sciences Issues Voluntary Nationwide Recall of ION* Sinus Support, ION* Biome Sinus, and Restore Sinus Spray Products Due to Microbial Contamination
• KVK-Tech, Inc. Issues Voluntary Nationwide Recall of One Lot of Betaxolol Tablets, USP 10 mg Due to a Single Foreign Tablet Found During the Line Clearance After the Batch was Packaged

October 2, 2023

• Hospira, Inc. Issues a Voluntary Nationwide Recall for Sodium Bicarbonate Injection and Lidocaine HCl Injection Due to the Potential for Presence of Glass Particulate Matter

October 10, 2023

• Family Dollar Voluntary Recall of Certain Over-the-Counter Drugs and Medical Devices
• FDA Warns Patients and Health Care Providers About Potential Risks Associated With Compounded Ketamine Products

October 22, 2023

• Botanical-Be Issues Voluntary Nationwide Recall of Kuka Flex Forte, Artri King, and Reumo Flex (Capsules) Due to Presence of Undeclared Diclofenac

October 25, 2023

• Exela Issues Voluntary Nationwide Recall of Sodium Bicarbonate 8.4%, Midazolam in 0.8% Sodium Chloride, and ELCYS Injections Due to Presence of Particulate Matter

October 26, 2023

• FDA Raises Concerns About Probiotic Products Sold for Use in Hospitalized Preterm Infants

October 30, 2023

• FDA Warns Consumers Not To Purchase or Use Certain Eye Drops From Several Major Brands Due to Risk of Eye Infection

October 31, 2023

• Cardinal Health, Inc. Issues Voluntary Nationwide Recall of Certain LEADER™ Brand Eye Drops Supplied by Velocity Pharma, LLC Due to Potential Risk of Eye Infections
• The Harvard Drug Group, LLC Issues Voluntary Nationwide Recall of Certain Rugby® Laboratories Brand Eye Drops Supplied by Velocity Pharma, LLC Due to Potential Risk of Eye Infections

November 1, 2023

• Important Information About the Correct Dosage and Administration of Moderna COVID-19 Vaccine (2023-2024 Formula) for Individuals 6 Months Through 11 Years of Age

November 3, 2023

• FDA Warns Consumers of Hidden Drug Ingredients in Dr. Ergin’s SugarMD Advanced Glucose Support

November 6, 2023

• Nurse Assist, LLC Issues Recall of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP Nationwide and to Canada

November 8, 2023

• SugarMDs LLC Issues Voluntary Nationwide Recall of Advanced Glucose Support Supplements Capsules Due to Presence of Undeclared Glyburide and Metformin

November 13, 2023

• Kilitch Healthcare India Limited Issues Voluntary Nationwide Recall of Various Eye Drops for Potential Safety Reasons
• KinderFarms, LLC Voluntarily Recalling all KinderMed Pain & Fever Products Due to Acetaminophen Instability

November 17, 2023

• Bayer Issues Voluntary Recall Nationwide of Vitrakvi (larotrectinib) Oral Solution 20 mg/mL Due to Presence of Microbial Contamination

November 18, 2023

• Noah’s Wholesale, LLC Issues Voluntary Nationwide Recall of the Rock Due to Presence of Undeclared Sildenafil

November 21, 2023

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

November 24, 2023

• Novartis Issues Voluntary US Nationwide Recall of Two Lots of Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/mL Due to Crystallization
• Insight Pharmaceuticals Issues Voluntary Nationwide Recall of TING® 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder Due to the Presence of Benzene

November 28, 2023

• FDA Investigating Serious Risk of T-cell Malignancy Following BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies
• FDA Warns of Rare But Serious Drug Reaction to the Antiseizure Medicines Levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and Clobazam (Onfi, Sympazan)

December 9, 2023

• InvaGen Pharmaceuticals Issues Voluntary Nationwide Recall of Vigabatrin for Oral Solution, USP 500mg due to Leaking Sachets

December 13, 2023

• WS Global Issues Nationwide Recall of Himalayan Pain Relief Tea Due to the Presence of Hidden Drug Ingredients, Diclofenac and Dexamethasone

December 14, 2023

• 8th Avenue Pharmacy Issues Voluntary Nationwide Recall of Notoginseng Formula Special Gout Granule Due to the Presence of Hidden Drug Ingredients, Diclofenac and Dexamethasone

December 21, 2023

• Hospira, Inc. Issues A Voluntary Nationwide Recall For One Lot of Bleomycin for Injection, USP 15 Units Single Dose ONCO-TAIN™ Glass Fliptop Vial Due To The Potential For Presence of Glass Particulate Matter
• Hospira, Inc. Issues A Voluntary Nationwide Recall For 4.2% Sodium Bicarbonate Injection, 8.4% Sodium Bicarbonate Injection, and Atropine Sulfate Injection Due to the Potential Presence of Glass Particulate Matter
• FDA Warns Consumers Not to Use Counterfeit Ozempic (semaglutide) Found in U.S. Drug Supply Chain

December 22, 2023

• Insight Pharmaceuticals Issues Voluntary Nationwide Recall of Americaine® 20% Benzocaine Topical Anesthetic Spray Due to the Presence of Benzene

December 27, 2023

• FDA Requires Updates to Labeling for Promethazine Hydrochloride Injection Products