FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Ongoing Mar 20, 2026
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing Mar 20, 2026
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing Mar 20, 2026
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing Mar 20, 2026
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing Mar 20, 2026
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing Mar 20, 2026
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing Mar 20, 2026
Reason This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
Class II · Moderate risk Ongoing Mar 20, 2026
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class II · Moderate risk Ongoing Mar 20, 2026
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class II · Moderate risk Ongoing Mar 20, 2026
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class II · Moderate risk Ongoing Mar 20, 2026
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class II · Moderate risk Ongoing Mar 20, 2026
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class II · Moderate risk Ongoing Mar 19, 2026
Reason CGMP Deviations: use of an unapproved raw material
Class II · Moderate risk Ongoing Mar 19, 2026
Reason CGMP Deviations: use of an unapproved raw material
Class II · Moderate risk Ongoing Mar 19, 2026
Reason CGMP Deviations: use of an unapproved raw material
Class II · Moderate risk Ongoing Mar 19, 2026
Reason Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability…
Class III · Low risk Terminated Mar 18, 2026
Reason Subpotent Drug
Class III · Low risk Terminated Mar 18, 2026
Reason Subpotent Drug
Class III · Low risk Terminated Mar 18, 2026
Reason Subpotent Drug
Class I · High risk Ongoing Mar 18, 2026
Reason Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
Class II · Moderate risk Ongoing Mar 17, 2026
Reason Labelling: Illegible label
Class II · Moderate risk Ongoing Mar 17, 2026
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing Mar 17, 2026
Reason Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the…
Class II · Moderate risk Ongoing Mar 17, 2026
Reason Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the…
Class II · Moderate risk Ongoing Mar 17, 2026
Reason Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the…