Antibiotic Recalls
Recalls of antibiotics used to treat bacterial infections.
192 recalls in this category, newest first.
Class II · Moderate risk Terminated Jun 1, 2017
Reason Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical…
Class III · Low risk Terminated Apr 26, 2017
Reason Subpotent Drug; Clavulanic Acid
Class II · Moderate risk Terminated Mar 10, 2017
Reason Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and…
Class II · Moderate risk Terminated Mar 10, 2017
Reason Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and…
Class III · Low risk Terminated Feb 28, 2017
Reason CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
Class III · Low risk Terminated Feb 24, 2017
Reason Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg
Class II · Moderate risk Terminated Feb 22, 2017
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk Terminated Feb 10, 2017
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated Feb 10, 2017
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated Feb 10, 2017
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated Feb 10, 2017
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated Feb 10, 2017
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated Feb 10, 2017
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated Feb 10, 2017
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated Feb 10, 2017
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated Feb 10, 2017
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated Feb 10, 2017
Reason Lack of Sterility Assurance: customer report of leaking bag
Class II · Moderate risk Terminated Dec 28, 2016
Reason Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap
Class II · Moderate risk Terminated Dec 21, 2016
Reason Subpotency: due to a low, out of specification test result for assay during stability testing.
Class III · Low risk Terminated Nov 4, 2016
Reason Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
Class III · Low risk Terminated Aug 18, 2016
Reason Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
Class II · Moderate risk Terminated Jul 7, 2016
Reason CGMP Deviations
Class II · Moderate risk Terminated Jul 7, 2016
Reason CGMP Deviations
Class II · Moderate risk Terminated Jun 24, 2016
Reason Superpotent drug: Out of specification test result for assay during stability testing.
Class III · Low risk Terminated Jun 1, 2016
Reason Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.