Class II · Moderate risk
Ciclopirox Shampoo
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Is Ciclopirox recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Ciclopirox (7 total). Check the affected lots below.
Most common reason: Impurity / degradation (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ciclopirox. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Ciclopirox recalls on record
none so far in 2026; 7 on record, newest first
Class III · Low risk
Ciclopirox Gel 0.77%
Defective Container: Firm received complaints of broken tube at the seal.
Class II · Moderate risk
Ciclopirox Topical Solution 8%
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class III · Low risk
Ciclopirox shampoo 1%
Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
Class III · Low risk
Ciclopirox Olamine Cream USP
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Class III · Low risk
Ciclopirox Olamine Cream USP
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Class III · Low risk
Ciclopirox Shampoo 1%
Subpotent. drug
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