Class III · Low risk Ongoing
Primidone Tablets
Reason Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
FDA Drug Recalls
17,898 recalls, newest first
Class III · Low risk Ongoing
Primidone Tablets
Reason Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class II · Moderate risk Ongoing
Oasis Tears PF
Reason 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 Ongoing
MG217 Multi-Symptom Treatment Cream & Skin Protectant
Reason Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
Class II · Moderate risk Ongoing
Liraglutide Injection
Reason Presence of particulate matter: a white thread-like structure in the cartridge
Class III · Low risk Ongoing
Primidone Tablets USP
Reason Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class II · Moderate risk Ongoing
Octreotide Acetate for Injectable Suspension
Reason 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 Ongoing
Enalapril Maleate Tablets
Reason Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Class II · Moderate risk Ongoing
Similasan
Reason 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 Ongoing
iVIZIA
Reason 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 Ongoing
BD PurPrep
Reason Lack of assurance of Sterility: potential product contamination
Class II · Moderate risk Ongoing
BD PurPrep
Reason Lack of assurance of Sterility: potential product contamination
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules USP
Reason CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II · Moderate risk Ongoing
GenTeal Tears
Reason Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Class II · Moderate risk Ongoing
Systane
Reason Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Class II · Moderate risk Ongoing
Naproxen Oral Suspension
Reason Chemical contamination; presence of lead and lithium above specification
Class II · Moderate risk Ongoing
Optase Dry Eye Intense Drops
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Freshkote Lubricant Eyedrops
Reason Lack of Assurance of Sterility
Class III · Low risk Ongoing
Levocarnitine Injection
Reason Labeling: Missing Label
Class III · Low risk Ongoing
Premier
Reason 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.
Class III · Low risk Ongoing
busPIRone Hydrochloride Tablets
Reason Subpotent drug
Class II · Moderate risk Ongoing
Omega-3-Acid
Reason Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Class II · Moderate risk Ongoing
Revitaderm Wound Care
Reason CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Class II · Moderate risk Ongoing
Fungal Fusion ERADICATION Solution
Reason CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Class II · Moderate risk Ongoing
TERPENICOL Antifungal Solution
Reason CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry