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Class IIOngoing

vite20 Antifungal Cream recall

FDA recall D-0696-2026 · initiated Apr 8, 2026

By the pharmaranks editorial teamReviewed against the FDA (openFDA) sourcesUpdated Jul 8, 2026How we research

Blaine Labs Inc recalled vite20 Antifungal Cream in Apr 2026 — an FDA Class II recall (D-0696-2026) because CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry.

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

Wrong strength, or it did not keep

The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.

This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.

Is your product affected? Check the lot number

A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.

Lot BL3462, Exp. 2/7/2027

Quantity recalled: 26,475 bottles

Details

Product
vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, UPC 6 16728 00039 2.
Recalling company
Blaine Labs Inc
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
Nationwide in the USA
Initiated
Apr 8, 2026
FDA report date
Jul 8, 2026
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Frequently asked

Was vite20 Antifungal Cream recalled?
Blaine Labs Inc recalled vite20 Antifungal Cream in Apr 2026 — an FDA Class II recall (D-0696-2026) because CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry. May cause temporary or medically reversible harm; low probability of serious harm.
Why was vite20 Antifungal Cream recalled?
Per the FDA enforcement record, the reason for recall D-0696-2026 was: CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Is a recalled vite20 Antifungal Cream dangerous to take?
An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
Which lots of vite20 Antifungal Cream are affected?
Distributed: Nationwide in the USA. The recall covers these lots — Lot BL3462, Exp. 2/7/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0696-2026.

Source: openFDA Drug Enforcement record D-0696-2026

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