FDA recall H-0589-2025

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.

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.

Key facts

Status

Terminated

Initiation date

2025-08-06

Report date

2025-09-24

Termination date

2026-02-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Norcross, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=H-0589-2025