Piperacillin and Tazobactam for Injection
Lack of Assurance of Sterility
Most common reason: Sterility / contamination (19 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Tazobactam. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of sterility assurance
Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. While all product distributed to the market has met the registered specifications for release, including for sterility, it was manufactured on the same equipment as the affected batches.
Presence of Particulate Matter: identified as glass and silicone material
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
Lack of Sterility Assurance
Lack of Sterility Assurance
Lack of Sterility Assurance
Lack of Assurance of Sterility
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Lack of sterility assurance.
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
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