💊 Drugs • 12,141 recalls
JB Chemicals and Pharmaceuticals
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
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.
Subpotent drug
Breckenridge Pharmaceutical
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
B BRAUN MEDICAL
Presence of Particulate Matter.
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
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.
Hikma Pharmaceuticals USA
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Labeling: Missing Label
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
B BRAUN MEDICAL
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Premier Dental Products
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.
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
B BRAUN MEDICAL
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
SUN PHARMACEUTICAL INDUSTRIES
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Xiamen Kang Zhongyuan Biotechnology Co.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Xiamen Kang Zhongyuan Biotechnology Co.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.