Class I Drug Recalls

The 20 most recently initiated drug recalls from FDA enforcement reports, limited to Class I - Dangerous recalls. Class I means a reasonable probability of serious harm or death, Class II a temporary or reversible health risk, and Class III a product unlikely to cause harm. Dates are recall initiation dates.

AllClass IClass IIClass III
Class I2026-08-21
Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine (T4) 19 mcg, liothyronine (T3) 4.5 mcg, 100 Tablets, Rx only, Distributed

Superpotent Drug

VITRUVIAS THERAPEUTICS INC
Class I2026-08-19
0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018 USA, ND

Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber

B BRAUN MEDICAL INC
Class I2026-08-17
0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015, US

Presence of particulate matter: Particulates identified as fiberglass

Baxter Healthcare Corporation
Class I2026-08-17
Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06

Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.

Baxter Healthcare Corporation
Class I2026-08-12
Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-00

Presence of Particulate matter.

B BRAUN MEDICAL INC
Class I2026-08-11
Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AME

Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, a

American Regent, Inc.
Class I2026-08-10
Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 6

Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.

Fresenius Kabi USA, LLC
Class I2026-08-05
Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For

Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

OPTIMAL BALANCE PHARMACY
Class I2026-08-04
Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi

Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.

Fresenius Kabi USA, LLC
Class I2026-07-31
Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Ma

Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.

Liebel-Flarsheim Company LLC
Class I2026-07-24
Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Vials (NDC 051

Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde

American Regent, Inc.
Class I2026-07-24
Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx o

Presence of Particulate Matter

Baxter Healthcare Corporation
Class I2026-07-17
Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018

Presence of Particulate Matter; identified as stainless steel

Sunny Pharmtech Inc.
Class I2026-07-17
Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018

Presence of Particulate Matter; identified as stainless steel

Sunny Pharmtech Inc.
Class I2026-07-01
Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Adjust) in s

Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

Victory Medical Center Pharmacy
Class I2026-06-24
Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals

Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed

JB Chemicals and Pharmaceuticals Ltd
Class I2026-06-04
Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed

Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the pa

Haleon US Holdings LLC
Class I2026-06-01
BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle, Manufactured For: Beekeepe

Microbial Contamination of Non-Sterile Products

BEEKEEPER'S NATURALS USA INC.
Class I2026-05-28
BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Ster

Non-Sterility: Due to presence of Aspergillus penicillioides.

CareFusion 213, LLC
Class I2026-05-28
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Soluti

Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the

CareFusion 213, LLC