Class II · Moderate risk
Ceftriaxone for Injection
Lack of Assurance of Sterility
Is Ceftriaxone recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Ceftriaxone (38 total). Check the affected lots below.
Most common reason: Sterility / contamination (26 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ceftriaxone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Ceftriaxone recalls on record
none so far in 2026; 38 on record, newest first
Class II · Moderate risk
Ceftriaxone for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ceftriaxone for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ceftriaxone for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ceftriaxone for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ceftriaxone for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ceftriaxone for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ceftriaxone for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ceftriaxone for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ceftriaxone for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ceftriaxone
Lack of sterility assurance
Class II · Moderate risk
Ceftriaxone
Lack of sterility assurance
Class II · Moderate risk
CefTRIAXone 1 GM
Lack of sterility assurance.
Class I · High risk
Ceftriaxone for Injection USP
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Class I · High risk
Ceftriaxone for Injection USP
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Class I · High risk
Ceftriaxone for Injection USP
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Class I · High risk
Ceftriaxone for Injection USP
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Class III · Low risk
Ceftriaxone for Injection
Labeling: Missing Label
Class III · Low risk
CEFTRIAXONE for Injection USP
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
Class II · Moderate risk
Ceftriaxone 1GM injection in Sterile Water
Lack of Assurance of Sterility
Class II · Moderate risk
Ceftriaxone 2 gram in 100 mL 0.9% NS bags
Lack of Sterility Assurance
Class II · Moderate risk
Ceftriaxone 2 gram Add-Vantage in 100 mL 0.45% NS bag
Lack of Sterility Assurance
Class II · Moderate risk
Ceftriaxone 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bags
Lack of Sterility Assurance
Class III · Low risk
Ceftriaxone Sodium
CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
Class III · Low risk
Ceftriaxone for Injection USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
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