Class II · Moderate risk
Cefixime for Oral Suspension USP
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Is Cefixime recalled?
Not under an active recall.
Cefixime was recalled 12 times in the past — all now closed. Most recent: Aug 21, 2024.
Most common reason: Impurity / degradation (6 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Cefixime. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Cefixime recalls on record
none so far in 2026; 12 on record, newest first
Class II · Moderate risk
Cefixime for Oral Suspension USP 200 mg/5 mL
Failed Content Uniformity Specifications
Class II · Moderate risk
Cefixime for Oral Suspension 100mg/5mL
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Cefixime 400 mg capsule
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Cefixime Capsules
Failed impurities/degradation specifications
Class II · Moderate risk
Cefixime Capsules 400 mg
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Cefixime for Oral Suspension USP 100 mg/5mL
Subpotent Drug
Class II · Moderate risk
Cefixime for Oral Suspension USP
Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
Class II · Moderate risk
Cefixime active pharmaceutical ingredient packaged in varying grams or kg in bags or drums
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class III · Low risk
Suprax
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Class III · Low risk
Suprax
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Class III · Low risk
Suprax (cefixime for oral suspension)
Discoloration; Product may not meet specifications for color description once reconstituted.
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