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Class IIOngoing

Little Moon Essentials recall

FDA recall D-0577-2024 · initiated Jun 20, 2024

By the pharmaranks editorial teamReviewed against the FDA (openFDA) sourcesUpdated Jul 10, 2024How we research

Little Moon Essentials LLC recalled Little Moon Essentials in Jun 2024 — an FDA Class II recall (D-0577-2024) because CGMP deviations.

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

Why it was recalled

CGMP deviations

The manufacturing process itself

The FDA found the process itself out of compliance, usually before any defective product was identified.

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 code no expiration date on product: a) 322230, 424040, b) 322230, 325070, 324080, 325180, 325280, 328290, 426110, 423210, 426120, 422220, 423130, 428230, 325040

Quantity recalled: 320 metal tins

Details

Product
Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88227 5, NDC 70722-216-05; b) 3 OZ (85-05G) metal tin UPC Code 6 73673 88216 9, NDC 70722-216-03; Little Moon Essentials LLC Dania Beach, Fl 33004
Recalling company
Little Moon Essentials LLC
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
Nationwide USA and Ontario, Canada (2 retailers)
Initiated
Jun 20, 2024
FDA report date
Jul 10, 2024
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 Little Moon Essentials recalled?
Little Moon Essentials LLC recalled Little Moon Essentials in Jun 2024 — an FDA Class II recall (D-0577-2024) because CGMP deviations. May cause temporary or medically reversible harm; low probability of serious harm.
Why was Little Moon Essentials recalled?
Per the FDA enforcement record, the reason for recall D-0577-2024 was: CGMP deviations
Is a recalled Little Moon Essentials 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 Little Moon Essentials are affected?
Distributed: Nationwide USA and Ontario, Canada (2 retailers). The recall covers these lots — lot code no expiration date on product: a) 322230, 424040, b) 322230, 325070, 324080, 325180, 325280, 328290, 426110, 423210, 426120, 422220, 423130, 428230, 325040. 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-0577-2024.

Source: openFDA Drug Enforcement record D-0577-2024

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