Every FDA drug recall initiated in 2025, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
778 recalls, newest first.
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Defective Container - A defect in the side-seal which allows leakage of product.
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Defective container - seal not adhering to bottles
Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges
Defective container: cracked/broken cartridges
cGMP deviations
cGMP deviations
cGMP deviations
cGMP deviations
cGMP deviations
cGMP deviations
cGMP deviations
cGMP deviations