Class II · Moderate risk
C-Urea 40% Bladder Instill
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Is Urea recalled?
Not under an active recall.
Urea was recalled 7 times in the past — all now closed. Most recent: Jul 24, 2019.
Most common reason: Failed specification (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Urea. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Urea recalls on record
none so far in 2026; 7 on record, newest first
Class II · Moderate risk
UREA 40% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class III · Low risk
Urea (50% Urea in a Cream Base)
Crystallization; complaints received by the manufacturer of crystals forming in product
Class III · Low risk
Remeven Cream
Crystallization; Complaints that cream appears to have crystallized
Class II · Moderate risk
All Germall
Lack of Processing Controls
Class II · Moderate risk
Carbo-O-Philic 40 Gel 40%
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Class II · Moderate risk
Carbo-O-Philic 40 Cream 40%
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
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