Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
FDA drug recalls in 2026
Every FDA drug recall initiated in 2026, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
563 recalls, newest first.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Class I · High risk
Lactated Ringer's Injection USP
Presence of Particulate Matter.
Class II · Moderate risk
Ascend Laboratories
Failed Dissolution Specifications
Class III · Low risk
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class III · Low risk
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class II · Moderate risk
Oasis Tears PF
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
Class I · High risk
MG217 Multi-Symptom Treatment Cream & Skin Protectant
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
Class II · Moderate risk
Liraglutide Injection
Presence of particulate matter: a white thread-like structure in the cartridge
Class III · Low risk
Primidone Tablets USP
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk
Enalapril Maleate Tablets
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Class II · Moderate risk
Similasan
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Class II · Moderate risk
iVIZIA
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Class II · Moderate risk
BD PurPrep
Lack of assurance of Sterility: potential product contamination
Class II · Moderate risk
BD PurPrep
Lack of assurance of Sterility: potential product contamination
Class II · Moderate risk
Duloxetine Delayed-Release Capsules USP
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II · Moderate risk
GenTeal Tears
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Class II · Moderate risk
Systane
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Class II · Moderate risk
Naproxen Oral Suspension
Chemical contamination; presence of lead and lithium above specification
Class II · Moderate risk
Optase Dry Eye Intense Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Freshkote Lubricant Eyedrops
Lack of Assurance of Sterility
Class III · Low risk
Levocarnitine Injection
Labeling: Missing Label
Class III · Low risk
Premier
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.