Class II · Moderate risk
Pentosan Polysulfate Sodium 250mg/mL
Lack of Assurance of Sterility
Pentosan for Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Pentosan for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Drug: Pentosan
- Recalling firm
- GenoGenix LLC
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0078-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Pentosan recalls
See all
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
Other recalls by GenoGenix LLC
All 2025 recalls
Class I · High risk
NAD+ (Nicotinamide adenine dinucleotide)
Microbial Contamination of Sterile Products: elevated endotoxin levels
Class II · Moderate risk
Retatrutide for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide for Injection
Lack of Assurance of Sterility
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