Fruit Of The Earth, Inc. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • Latest inspection NAI · Dec 18, 2025
  • No warning letters matched by name
Inspections 14 1 OAI
Recalls 2 0 Class I (0%)
Warning letters 0 None on file
510(k) clearances 0 None on file

Fruit Of The Earth, Inc. has 2 FDA recalls, 14 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Fruit Of The Earth, Inc." is on file.

What these totals cover: FDA records filed under the name "Fruit Of The Earth, Inc." and its spelling variant "Fruit Of The Earth".

Latest recall
D-0284-2025 · Class II · Mar 11, 2025
Latest inspection
Dec 18, 2025 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls2Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections14Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Fruit Of The Earth, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Fruit Of The Earth, Inc.: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202530020
202400000
202330000
202200000
202110000
202000000
201900000
201810000
201710000

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.

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Recent recalls

2 recall records on Mar 11, 2025.

NumberClassProductDate
D-0284-2025Class IICVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by…Mar 11, 2025
D-0283-2025Class IIWalgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz…Mar 11, 2025

Recent FDA inspections

14 inspections from May 29, 2009 to Dec 18, 2025.

DateSiteProductClassificationFEI
Dec 18, 2025Grand Prairie, TXFood/CosmeticsNo Action Indicated (NAI)1420298
Dec 11, 2025Grand Prairie, TXFood/CosmeticsNo Action Indicated (NAI)3011333791
Mar 21, 2025Fort Worth, TXDrugsVoluntary Action Indicated (VAI)3012301642
Oct 10, 2023Fort Worth, TXFood/CosmeticsNo Action Indicated (NAI)3012301642
Apr 14, 2023Grand Prairie, TXFood/CosmeticsNo Action Indicated (NAI)1420298
Mar 31, 2023Grand Prairie, TXDrugsVoluntary Action Indicated (VAI)1420298
Dec 22, 2021Grand Prairie, TXFood/CosmeticsVoluntary Action Indicated (VAI)1420298
Oct 24, 2018Fort Worth, TXDrugsNo Action Indicated (NAI)3012301642
Apr 13, 2017Grand Prairie, TXDrugsVoluntary Action Indicated (VAI)1420298
Oct 19, 2016Grand Prairie, TXDrugsNo Action Indicated (NAI)3011333791
Mar 3, 2015Grand Prairie, TXFood/CosmeticsVoluntary Action Indicated (VAI)1420298
Jan 30, 2014Grand Prairie, TXFood/CosmeticsVoluntary Action Indicated (VAI)1420298
Jan 3, 2012Grand Prairie, TXDrugsOfficial Action Indicated (OAI)1420298
May 29, 2009Grand Prairie, TXDrugsVoluntary Action Indicated (VAI)1420298
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

3 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 1420298Grand Prairie, TX9Dec 18, 2025
FEI 3011333791Grand Prairie, TX2Dec 11, 2025
FEI 3012301642Fort Worth, TX3Mar 21, 2025

Fruit Of The Earth, Inc. and the FDA: common questions

Has Fruit Of The Earth, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Fruit Of The Earth, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Fruit Of The Earth, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Fruit Of The Earth, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Fruit Of The Earth, Inc.?

The most recent FDA inspection on file ended Dec 18, 2025 at Grand Prairie, TX and was classified NAI. FDA has 14 inspections of Fruit Of The Earth, Inc. on file, 1 of them classified OAI (official action indicated).

Has Fruit Of The Earth, Inc. had an FDA recall?

Yes. Fruit Of The Earth, Inc. has 2 FDA recalls on record. The most recent started Mar 11, 2025.

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