CEPHALEXIN

Generic: CEPHALEXIN

Aurobindo Pharma LimitedManufacturer

ORALRoute

CEPHALEXINActive Substance

2026-06-09Original Approval

CEPHALEXIN is FDA application ANDA213568, sponsored by AUROBINDO PHARMA. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2020-08-24

Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle wh

CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredie

Class II2019-01-09

Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryl

CGMP Deviations; presence of extraneous material in the was observed in area that is between the pr

Class III2024-05-10

Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: cephalexin monohydrate,

Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP eq

Class III2024-05-10

Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixed), Each contains cephalexin monohydrate, U

Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP eq

Class II2021-04-12

Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Suspension, 250 mg/5mL, Pkg Size 100, Rx only,

Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected

Class II2025-05-23

Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories

Failed Impurities/Degradation Specifications An out-of-specification result was observed in the rela

Class II2021-01-22

Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, L

CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side

Class II2020-12-17

Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by

Failed Impurity/Degradation Specifications

Class II2021-01-22

Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Lt

CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side

Class II2020-08-24

Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle wh

CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredie

CEPHALEXIN

Recalls

Top Reported Reactions