CAREone
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Yes — there is an active recall. 12 ongoing FDA recalls mention Carbamide (14 total). Check the affected lots below.
Most common reason: Wrong potency / content (12 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Carbamide. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
CGMP Deviations: products were stored outside the drug label specifications.
Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the 24-month expiration date printed on the packaging.
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