CLASS III Food recall · Reported 20 Aug 2025 · FDA Enforcement Report
a.) Actylis brand Lithium Orotate recalled by Aceto US
Aceto US is recalling a.) Actylis brand Lithium Orotate 4%, distributed in 8 states. The recall was initiated on 24 Jun 2025 and the FDA has classified it as Class III.
Check your package
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
Recall details
- Recall number
- H-0441-2025
- FDA event ID
- 97147
- Recalling firm
- Aceto US, Port Washington, NY
- Brand
- Actylis
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 24 Jun 2025
- FDA classified
- 8 Aug 2025
- Reported
- 20 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Product category
- Other
Timeline
| 24 Jun 2025 | Recall initiated by company | |
| 8 Aug 2025 | Classified by FDA | +45 days |
| 20 Aug 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
NJ, NC, CA, UT, MT, FL, AZ, NC, NY
ArizonaCaliforniaFloridaMontanaNorth CarolinaNew JerseyNew YorkUtah
Questions about this recall
Is a.) Actylis brand Lithium Orotate 4% recalled?
Yes. Aceto US recalled a.) Actylis brand Lithium Orotate 4% on 24 Jun 2025. The recall is Class III and its status is Terminated. Recall number H-0441-2025.
Why was it recalled?
4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%
Which lots are affected?
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
Where was it sold?
NJ, NC, CA, UT, MT, FL, AZ, NC, NY
What should I do if I have it?
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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