Class II · Moderate risk
CARBOPLATIN 174 MG / 250ml NS IVPB
Lack of Assurance of Sterility
Is Carboplatin recalled?
Not under an active recall.
Carboplatin was recalled 8 times in the past — all now closed. Most recent: Jun 12, 2019.
Most common reason: Failed specification (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Carboplatin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Carboplatin recalls on record
none so far in 2026; 8 on record, newest first
Class I · High risk
CARBOplatin Injection 450 mg/45 mL
Presence of Particulate Matter
Class II · Moderate risk
Carboplatin active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged between 01/05/12 through 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 II · Moderate risk
CARBOplatin Injection
Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
Class I · High risk
Carboplatin Injection
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
Class I · High risk
Carboplatin Injection
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
Class III · Low risk
Carboplatin Injection
Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.
Class II · Moderate risk
Carboplatin Injection
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are beig recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
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