Antibiotic Recalls
Recalls of antibiotics used to treat bacterial infections.
192 recalls in this category, newest first.
Class II · Moderate risk Terminated Feb 12, 2024
Reason CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment…
Class II · Moderate risk Terminated Feb 7, 2024
Reason cGMP Deviations: Products were stored outside the drug label specifications.
Class III · Low risk Terminated Aug 23, 2023
Reason Defective Container: slow leakage under the cap
Class II · Moderate risk Terminated Dec 27, 2022
Reason Lack of sterility assurance
Class II · Moderate risk Terminated Dec 27, 2022
Reason Lack of sterility assurance
Class II · Moderate risk Terminated Dec 22, 2022
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Ongoing Oct 13, 2022
Reason CGMP Deviations:
Class II · Moderate risk Terminated Jun 10, 2022
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk Terminated Apr 13, 2022
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated Apr 13, 2022
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated Apr 13, 2022
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated Apr 13, 2022
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated Apr 13, 2022
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated Apr 13, 2022
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated Apr 13, 2022
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated Apr 13, 2022
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated Jan 26, 2022
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated Jan 26, 2022
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated Jan 26, 2022
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated Dec 16, 2021
Reason Subpotent
Class II · Moderate risk Terminated Dec 6, 2021
Reason CGMP Deviations
Class II · Moderate risk Terminated Dec 6, 2021
Reason CGMP Deviations
Class II · Moderate risk Terminated Nov 8, 2021
Reason Superpotent Drug
Class II · Moderate risk Ongoing Apr 12, 2021
Reason Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified…
Class II · Moderate risk Terminated Mar 15, 2021
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.