Recall archive / FDA food enforcement
HI-TECH PHARMACEUTICALS FISH OIL HEART AND BRAIN HEALTH EPA/DHA OMEGA 3 FATTY ACIDS SUPPORTS CARDIOVASCULAR HEALTH MA... — FDA record H-0589-2025
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 6, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class III
- Recalling firm
- Hi-Tech Pharmaceuticals Inc.
- Quantity
- 85,950 units total
- Agency-reported status
- Terminated
- Source record identifier
- H-0589-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot 517120551 Exp Date 04/30 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Product was shipped to the following states: 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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 24, 2025
- Recall initiation date
- Aug 6, 2025
- Center classification date
- Sep 12, 2025
- Termination date
- Feb 19, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.