FDA Drug Recalls
316 recalls, newest first
Class II · Moderate risk Ongoing Dec 29, 2023
Reason Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Class II · Moderate risk Ongoing Dec 29, 2023
Reason Presence of Foreign Tablets/Capsules
Class I · High risk Ongoing Dec 28, 2023
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk Ongoing Dec 28, 2023
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk Ongoing Dec 28, 2023
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk Ongoing Dec 28, 2023
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk Ongoing Dec 28, 2023
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk Ongoing Dec 28, 2023
Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class II · Moderate risk Ongoing Dec 28, 2023
Reason Lack of Sterility Assurance
Class II · Moderate risk Ongoing Dec 28, 2023
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was…
Class II · Moderate risk Ongoing Dec 28, 2023
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was…
Class II · Moderate risk Ongoing Dec 28, 2023
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was…
Class II · Moderate risk Ongoing Dec 28, 2023
Reason CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was…
Class I · High risk Ongoing Dec 26, 2023
Reason Microbial Contamination of Non-Sterile Products
Class I · High risk Ongoing Dec 26, 2023
Reason Microbial Contamination of Non-Sterile Products
Class III · Low risk Ongoing Dec 26, 2023
Reason Superpotent drug: Assay results were slightly above specification at the time zero point.
Class I · High risk Ongoing Dec 21, 2023
Reason Presence of particulate matter: glass
Class I · High risk Ongoing Dec 21, 2023
Reason Presence of Particulate Matter; identified as glass
Class I · High risk Ongoing Dec 21, 2023
Reason Presence of Particulate Matter; identified as glass
Class I · High risk Ongoing Dec 21, 2023
Reason Presence of Particulate Matter; identified as glass
Class II · Moderate risk Ongoing Dec 21, 2023
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Class II · Moderate risk Ongoing Dec 21, 2023
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Class II · Moderate risk Ongoing Dec 21, 2023
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Class II · Moderate risk Ongoing Dec 21, 2023
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Class II · Moderate risk Ongoing Dec 21, 2023
Reason MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.