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Sweetheart USA, LLC

FDA Regulatory Profile

Sweetheart USA, LLC has 1 FDA recall, 2 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Sweetheart USA, LLC" and its spelling variant "Sweetheart Usa".

Latest recall
F-0929-2025 · Class II · May 6, 2025
Latest inspection
May 5, 2025 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls1Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Sweetheart USA, LLC: FDA inspections per year 2017: 0 inspections020172018: 0 inspections020182019: 0 inspections020192020: 1 inspections120202021: 0 inspections020212022: 0 inspections020222023: 0 inspections020232024: 0 inspections020242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510010
202400000
202300000
202200000
202100000
202010000
201900000
201800000
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

1 recall record on May 6, 2025.

NumberClassProductDate
F-0929-2025Class IIGluten Free Vegan Peanut Butter Jam Cookie, Net Wt. 3.5 oz (200g), packaged individually in plasticMay 6, 2025

Recent FDA inspections

2 inspections from Jan 3, 2020 to May 5, 2025.

DateSiteProductClassificationFEI
May 5, 2025Sagamore Hills, OHFood/CosmeticsNo Action Indicated (NAI)3035113263
Jan 3, 2020Northfield, OHFood/CosmeticsVoluntary Action Indicated (VAI)3005574911
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

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3035113263Sagamore Hills, OH1May 5, 2025
FEI 3005574911Northfield, OH1Jan 3, 2020

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FDA data resources

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