Class I drugs recalls

FDA Class I recalls of drugs, newest first. Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.

94 recalls published between October 9, 2024 and September 23, 2026. Most common issues: sterility (27), microbial contamination (26), undeclared allergen (21), potency (2). 94 were FDA Class I, the most serious level.

• Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains:… recall
  FDA September 23, 2026 · Vitruvias Therapeutics Inc · Class I
• 0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB… recall
  FDA September 16, 2026 · B Braun Medical Inc · Class I
• Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL)… recall
  FDA September 16, 2026 · American Regent, Inc. · Class I
• Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only… recall
  FDA September 16, 2026 · Baxter Healthcare Corporation · Class I
• Glutathione 200 mg/mL, 30 mL sterile multidose vial… recall
  FDA September 9, 2026 · Optimal Balance Pharmacy · Class I
• 0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers… recall
  FDA September 9, 2026 · Baxter Healthcare Corporation · Class I
• Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500… recall
  FDA September 2, 2026 · B Braun Medical Inc · Class I
• Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial… recall
  FDA September 2, 2026 · Fresenius Kabi USA, LLC · Class I
• Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL)… recall
  FDA August 26, 2026 · American Regent, Inc. · Class I
• Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist… recall
  FDA August 26, 2026 · Fresenius Kabi USA, LLC · Class I
• Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose… recall
  FDA August 19, 2026 · Baxter Healthcare Corporation · Class I
• Optiray Imaging Bulk Package-350, Ioversol Injection 74%… recall
  FDA August 19, 2026 · Liebel-Flarsheim Company LLC · Class I
• Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200… recall
  FDA August 19, 2026 · Victory Medical Center Pharmacy · Class I
• Kian Pee Wan Capsules, 30-count bottles recall
  FDA August 19, 2026 · Buy-Herbal · Class I
• Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial… recall
  FDA August 12, 2026 · Sunny Pharmtech Inc. · Class I
• Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial… recall
  FDA August 12, 2026 · Sunny Pharmtech Inc. · Class I
• Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle… recall
  FDA July 29, 2026 · JB Chemicals and Pharmaceuticals Ltd · Class I
• Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%… recall
  FDA July 8, 2026 · Blaine Labs Inc · Class I
• BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70%… recall
  FDA July 1, 2026 · CareFusion 213, LLC · Class I
• BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v… recall
  FDA July 1, 2026 · CareFusion 213, LLC · Class I
• BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse… recall
  FDA June 17, 2026 · Beekeeper's Naturals USA Inc. · Class I
• Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS… recall
  FDA June 17, 2026 · Haleon US Holdings LLC · Class I
• DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL)… recall
  FDA June 17, 2026 · Sun Pharmaceutical Industries Inc · Class I
• MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal… recall
  FDA May 27, 2026 · Wisconsin Pharmacal Company · Class I
• Lactated Ringer's Injection USP, 1000 mL container, Rx only, B… recall
  FDA May 13, 2026 · B Braun Medical Inc · Class I
• Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag… recall
  FDA April 8, 2026 · Amneal Pharmaceuticals, LLC · Class I
• Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes… recall
  FDA March 25, 2026 · Cardinal Health 200, LLC · Class I
• MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7 recall
  FDA March 11, 2026 · StuffbyNainax · Class I
• Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box… recall
  FDA March 11, 2026 · Mohamed Hagar · Class I
• SILINTAN 25/pills, packaged in a 25-count bottle… recall
  FDA March 11, 2026 · ANTHONY TRINH, 123Herbals LLC · Class I
• UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled… recall
  FDA February 18, 2026 · McKesson · Class I
• Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt recall
  FDA February 11, 2026 · Handelnine Global LLC · Class I
• Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10… recall
  FDA February 11, 2026 · Green Lumber Holdings, LLC · Class I
• ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl recall
  FDA January 14, 2026 · Medinatura New Mexico, inc. · Class I
• ReBoost Nasal Spray, 0.68 fl recall
  FDA January 14, 2026 · Medinatura New Mexico, inc. · Class I
• Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials… recall
  FDA December 3, 2025 · Fresenius Kabi USA, LLC · Class I
• POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container… recall
  FDA November 26, 2025 · Otsuka ICU Medical LLC · Class I
• POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container… recall
  FDA November 26, 2025 · Otsuka ICU Medical LLC · Class I
• Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use… recall
  FDA October 22, 2025 · IntegraDose Compounding Services LLC · Class I
• NAD+ (Nicotinamide adenine dinucleotide) for Injection… recall
  FDA October 15, 2025 · GenoGenix LLC · Class I
• Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle… recall
  FDA September 24, 2025 · Unichem Pharmaceuticals USA Inc. · Class I
• 0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B… recall
  FDA September 10, 2025 · B Braun Medical Inc · Class I
• Lactated Ringers's Injection USP, 1000 mL container, Rx only, B… recall
  FDA September 10, 2025 · B Braun Medical Inc · Class I
• PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl recall
  FDA September 10, 2025 · DermaRite Industries, LLC · Class I
• KleenFoam, Antimicrobial Foam Soap with Aloe Vera… recall
  FDA September 10, 2025 · DermaRite Industries, LLC · Class I
• DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl recall
  FDA September 10, 2025 · DermaRite Industries, LLC · Class I
• DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E… recall
  FDA September 10, 2025 · DermaRite Industries, LLC · Class I
• Buffered Penicillin G Potassium for Injection… recall
  FDA July 9, 2025 · Sandoz Inc · Class I
• Cefazolin for Injection, USP, 1 gram per vial, Sterile… recall
  FDA July 9, 2025 · Sandoz Inc · Class I
• Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL)… recall
  FDA July 9, 2025 · Church & Dwight Inc · Class I
• ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton… recall
  FDA July 9, 2025 · Church & Dwight Inc · Class I
• ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton… recall
  FDA July 9, 2025 · Church & Dwight Inc · Class I
• UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg… recall
  FDA June 25, 2025 · Umary-USA.com · Class I
• UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg… recall
  FDA June 25, 2025 · Umary-USA.com · Class I
• Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only… recall
  FDA June 18, 2025 · Amneal Pharmaceuticals, LLC · Class I
• Male Ultra Pro, Unleash Your Force 2, 10 capsules per box… recall
  FDA June 18, 2025 · Saini Trade Inc · Class I
• ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box… recall
  FDA June 18, 2025 · Saini Trade Inc · Class I
• ELECTRO BUZZ, Dietary Supplement, 10 capsules per box… recall
  FDA June 18, 2025 · Saini Trade Inc · Class I
• MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box… recall
  FDA June 18, 2025 · Saini Trade Inc · Class I
• Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box… recall
  FDA June 18, 2025 · Saini Trade Inc · Class I