Kapsin Ointment
CGMP Deviations
Yes — there is an active recall. 9 ongoing FDA recalls mention Capsaicin (17 total). Check the affected lots below.
Most common reason: Failed specification (8 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Capsaicin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
CGMP Deviations
cGMP Deviations
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
CGMP DEVIATIONS
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.
Marketed without an approved NDA/ANDA
Labeling: Incorrect Instructions; The word not is missing from the following sentences "do bandage tightly or cover with any type of wrap except clothing and "do use with a heating pad or with other heat sources in the Drug Facts panel "Warning" section
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