Class II · Moderate risk
Pentosan for Injection
Lack of Assurance of Sterility
Is Pentosan recalled?
Yes — there is an active recall. 4 ongoing FDA recalls mention Pentosan (5 total). Check the affected lots below.
Most common reason: Sterility / contamination (4 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Pentosan. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Pentosan recalls on record
none so far in 2026; 5 on record, newest first
Class II · Moderate risk
Pentosan Polysulfate Sodium 250mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Pentosan Polysulfate
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
Pentosan Polysulfate Sodium active pharmaceutical ingredient…
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 II · Moderate risk
Pentosan 250 mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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