FDA Food recall H-0589-2025
HI-TECH PHARMACEUTICALS FISH OIL HEART AND BRAIN HEALTH EPA/DHA OMEGA 3 FATTY ACIDS SUPPORTS CARDIOVASCULAR HEALTH MAY HELP WITH JOINT PAIN…
- FDA Food
- Class III
- terminated
- Published 2025-09-24
On 2025-09-24 the FDA classified a Class III recall of HI-TECH PHARMACEUTICALS FISH OIL HEART AND BRAIN HEALTH EPA/DHA OMEGA 3 FATTY ACIDS SUPPORTS CARDIOVASCULAR HEALTH MAY HELP WITH JOINT PAIN… by Hi Tech Pharmaceuticals, citing unapproved Drug Claims.
Read the official FDA Food notice
| Agency | FDA Food |
|---|---|
| Recall number | H-0589-2025 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2025-08-06 |
| Published | 2025-09-24 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hi Tech Pharmaceuticals |
| Distribution | AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
HI-TECH PHARMACEUTICALS FISH OIL HEART AND BRAIN HEALTH EPA/DHA OMEGA 3 FATTY ACIDS SUPPORTS CARDIOVASCULAR HEALTH MAY HELP WITH JOINT PAIN MAY IMPROVE COGNITIVE FUNCTION 90 SOFT GELS UPC 8 11836 02585 9 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071
Reason
Unapproved Drug Claims.
Identifiers
| upc | 811836025859 |
|---|---|
| code_info | Lot 517120551 Exp Date 04/30 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/food/enforcement.json?search=recall_number:%22H-0589-2025%22
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