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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97147

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 24, 2025
Product types
Food
Classifications
Class III
Statuses
Completed
Recalling firm wording
Aceto US, L.L.C

Dossier provenance

Source snapshots represented here

  • openFDA Food Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

food · product 1 of 1

a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner in a 25kg carton b.) Actylis brand Lithium Orotate 9% packaged in HDPE Liner in a 25kg carton

H-0441-2025
Recall number
H-0441-2025
Initiated
June 24, 2025
Classification
Class III
Status
Completed
Recalling firm
Aceto US, L.L.C
Quantity
9%: 6033.45 Kg; 4%: 4485.95 Kg

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%

Code information

a.) SKU: TLIOR0104 and Lot Numbers: T250464; T250265; T250184; T240967; T240619; T240452; T240346; T230944; T20230304 b.) SKU: TLIOR0109 and Lot Numbers: T250409; T250353; T250310; T250124; T241240; T240936; T240560; T240125; T20230223; T20230403; T20220701; T20221002; T20221204

Distribution pattern

NJ, NC, CA, UT, MT, FL, AZ, NC, NY

Field note

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