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EPI Health, LLC

FDA Regulatory Profile

EPI Health, LLC has 4 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "EPI Health, LLC" and its spelling variant "Epi Health".

Latest recall
D-0474-2024 · Class II · Apr 23, 2024
Latest inspection
Sep 30, 2021 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls4Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

EPI Health, LLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

EPI Health, LLC: FDA inspections per year 2017: 0 inspections020172018: 1 inspections120182019: 0 inspections020192020: 0 inspections020202021: 1 inspections120212022: 0 inspections020222023: 0 inspections020232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400030
202300000
202200000
202110000
202000000
201900010
201810000
201700000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent recalls

4 recall records from Aug 26, 2019 to Apr 23, 2024.

NumberClassProductDate
D-0474-2024Class IIminolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bottle, Rx Only, Mfg…Apr 23, 2024
D-0473-2024Class IICloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g, Manufactured…Apr 23, 2024
D-0475-2024Class IIminolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg…Apr 23, 2024
D-0120-2020Class IIIminolira (minocycline hydrochloride) extended-release tablets 135 mg* Physician Sample Not for Sale…Aug 26, 2019

Recent FDA inspections

2 inspections from Oct 24, 2018 to Sep 30, 2021.

DateSiteProductClassificationFEI
Sep 30, 2021Charleston, SCDrugsNo Action Indicated (NAI)3013519366
Oct 24, 2018Charleston, SCDrugsNo Action Indicated (NAI)3013519366
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3013519366Charleston, SC2Sep 30, 2021

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FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.