Calcipotriene Topical Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Yes — there is an active recall. 1 ongoing FDA recall mention Calcipotriene (6 total). Check the affected lots below.
Most common reason: Stability / shelf life (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Calcipotriene. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.
Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
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.
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