HI-TECH PHARMACEUTICALS FISH OIL HEART AND BRAIN HEALTH EPA/DHA OMEGA… — Class III food recall H-0589-2025
Terminated recall by Hi-Tech Pharmaceuticals Inc., reported 2025-09-24, distributed in AL, AR, AZ, CA, CO, CT, DE, FL…. Unapproved Drug Claims.
| Recall number | H-0589-2025 |
|---|---|
| Product type | Food |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hi-Tech Pharmaceuticals Inc., Norcross, GA, United States |
| Recall initiated | 2025-08-06 |
| Classified | 2025-09-12 |
| Reported by FDA | 2025-09-24 |
| Terminated | 2026-02-19 |
| Distributed | AL, AR, AZ, CA, CO, CT, DE, FL, GA, GU, 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 |
| Quantity | 85,950 units |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 00811836025859 |
| Lot numbers | 04/30, 517120551 |
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 for recall
Unapproved Drug Claims.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/H-0589-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.