Is Cephalexin recalled?
24 FDA recalls mention Cephalexin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Cephalexin.
Class II · Moderate risk Ongoing May 23, 2025
Reason Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of…
Class II · Moderate risk Ongoing May 23, 2025
Reason Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of…
Class III · Low risk Ongoing May 10, 2024
Reason Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle…
Class III · Low risk Ongoing May 10, 2024
Reason Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of…
Class III · Low risk Ongoing May 10, 2024
Reason Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle…
Class III · Low risk Ongoing May 10, 2024
Reason Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle…
Class III · Low risk Ongoing May 10, 2024
Reason Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of…
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 Jan 22, 2021
Reason CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Class II · Moderate risk Terminated Jan 22, 2021
Reason CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Class II · Moderate risk Terminated Dec 17, 2020
Reason Failed Impurity/Degradation Specifications
Class II · Moderate risk Terminated Dec 17, 2020
Reason Failed Impurity/Degradation Specifications
Class II · Moderate risk Terminated Nov 23, 2020
Reason Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS…
Class II · Moderate risk Terminated Aug 24, 2020
Reason Sub-Potent Drug: Out of specification test results for potency (below specification).
Class II · Moderate risk Terminated Aug 24, 2020
Reason CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Class II · Moderate risk Terminated Aug 24, 2020
Reason CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Class III · Low risk Terminated Nov 1, 2019
Reason Presence of Foreign substance: identified as a dead ant.
Class II · Moderate risk Terminated Jan 9, 2019
Reason CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary…
Class II · Moderate risk Terminated Jan 7, 2019
Reason CGMP Deviation; manufacturing batch record could not be located
Class II · Moderate risk Terminated Nov 14, 2014
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Terminated Nov 14, 2014
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Terminated Sep 22, 2014
Reason CGMP deviations: Products were manufactured with active pharmaceutical ingredients that were not manufactured with good manufacturing practices.
Class II · Moderate risk Terminated Jun 26, 2014
Reason CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not…
Class II · Moderate risk Terminated Jun 26, 2014
Reason CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not…