CEFIXIME
Generic: CEFIXIME
Aurobindo Pharma LimitedManufacturer
ORALRoute
CEFIXIMEActive Substance
2026-03-23Original Approval
CEFIXIME is FDA application ANDA217607, sponsored by AUROBINDO PHARMA LTD. 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 II2024-05-30
Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: LFailed Content Uniformity Specifications
Class II2021-12-21
Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, DistributFailed impurities/degradation specifications
Class II2021-04-29
Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc. BaSubpotent Drug
Class II2020-04-15
Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 2Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
Class II2021-11-03
Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, IndiFailed Impurities/Degradation Specifications
Class II2024-01-03
Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore,Failed Impurities/Degradation Specifications
Class II2024-08-21
Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., BalSubpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long t
Top Reported Reactions
1
DRUG INEFFECTIVE
288 reports
2
OFF LABEL USE
278 reports
3
PYREXIA
168 reports
4
DIARRHOEA
165 reports
5
NAUSEA
164 reports
6
PAIN
154 reports
7
MALAISE
137 reports
8
FATIGUE
136 reports
9
DYSPNOEA
133 reports
10
HEADACHE
132 reports