Class II · Moderate risk
Donepezil HCl Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Is Donepezil recalled?
Not under an active recall.
Donepezil was recalled 6 times in the past — all now closed. Most recent: Jan 26, 2022.
Most common reason: Wrong potency / content (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Donepezil. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Donepezil recalls on record
none so far in 2026; 6 on record, newest first
Class II · Moderate risk
Donepezil HCl Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class III · Low risk
Donepezil HCL Tablets
Subpotent
Class II · Moderate risk
Namzaric (memantine HCl extended release and donepezil HCl)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk
Donepezil HCl tablets
Supotent: Out of Specification result for assay test during routine stability testing.
Class III · Low risk
Donepezil Hydrochloride Tablets
Subpotent Drug: out of specification results for assay test.
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