FDA Drug Recalls
557 recalls, newest first
Class III · Low risk Ongoing Jun 24, 2024
Reason Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Class II · Moderate risk Ongoing Jun 24, 2024
Reason Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Class III · Low risk Ongoing Jun 24, 2024
Reason Sub-potent Drug
Class I · High risk Terminated Jun 21, 2024
Reason Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81…
Class II · Moderate risk Terminated Jun 21, 2024
Reason Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Class II · Moderate risk Ongoing Jun 20, 2024
Reason CGMP deviations
Class II · Moderate risk Ongoing Jun 20, 2024
Reason CGMP deviations
Class II · Moderate risk Ongoing Jun 20, 2024
Reason CGMP deviations
Class II · Moderate risk Ongoing Jun 20, 2024
Reason CGMP deviations
Class II · Moderate risk Ongoing Jun 20, 2024
Reason CGMP deviations
Class II · Moderate risk Ongoing Jun 20, 2024
Reason CGMP deviations
Class II · Moderate risk Ongoing Jun 20, 2024
Reason CGMP deviations
Class II · Moderate risk Ongoing Jun 20, 2024
Reason CGMP deviations
Class II · Moderate risk Ongoing Jun 18, 2024
Reason This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Class II · Moderate risk Terminated Jun 18, 2024
Reason Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Class III · Low risk Terminated Jun 18, 2024
Reason Subpotent drug: out of specification results
Class II · Moderate risk Ongoing Jun 17, 2024
Reason Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Class II · Moderate risk Terminated Jun 17, 2024
Reason Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Class II · Moderate risk Ongoing Jun 12, 2024
Reason Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C
Class II · Moderate risk Ongoing Jun 10, 2024
Reason Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Class II · Moderate risk Terminated Jun 7, 2024
Reason Presence of foreign substance.
Class II · Moderate risk Terminated Jun 5, 2024
Reason Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
Class I · High risk Terminated Jun 5, 2024
Reason Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
Class III · Low risk Ongoing Jun 4, 2024
Reason Failed Impurities/Degradation Specifications: Related Substances
Class II · Moderate risk Ongoing Jun 4, 2024
Reason Subpotent Drug