Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL recall — FDA D-0081-2025
Presence of Particulate Matter: Potential for glass delamination from the vials.
Complete FDA and NHTSA recall records dated in 2024, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Presence of Particulate Matter: Potential for glass delamination from the vials.
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Presence of Particulate Matter: Potential for glass delamination from the vials.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
CGMP violations.
cGMP Deviations
CGMP violations.
cGMP Deviations
Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.
Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Hyundai Motor America (Hyundai) is recalling certain 2025 Tucson and Santa Cruz vehicles. The console extension wiring assembly may be routed improperly, allowing the transmission to be…
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.