404 recalls · Class II, newest first
Reason CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason CGMP Deviations: use of an unapproved raw material
Reason CGMP Deviations: use of an unapproved raw material
Reason CGMP Deviations: use of an unapproved raw material
Reason Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability…