Yes — there is an active recall. 2 ongoing FDA recalls mention Ondansetron (24 total). Check the affected lots below.
Most common reason: Sterility / contamination (9 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ondansetron. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Failed pH Specifications
Lack of sterility assurance
Lack of assurance of sterility.
cGMP deviations: Temperature abuse
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Failed Impurities/Degradation Specifications.
Lack of Processing Controls.
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Microbial Contamination of Non-Sterile Product
CGMP Deviations
Lack of Assurance of Sterility
Failed Impurities/Degradation Specifications; 12 month stability time point
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Stability data does not support expiry.
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.
Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) were identified during site inspection of the vials.
Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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