LOW RISK Terminated 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 MAY IMPROVE COGNITIVE FUNCTION 90 SOFT GELS UPC 8 11836 02585 9 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071

Recalled by Hi-Tech Pharmaceuticals Inc.

Classification

Class III — Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws.

Reason for Recall

Unapproved Drug Claims.

Product Details

Product Quantity

85,950 units total

Product Type

Food

Code Info

Lot 517120551 Exp Date 04/30

Voluntary/Mandated

Voluntary: Firm initiated

Distribution & Geography

Distribution Pattern

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.

Company Location

Norcross, GA, 30071-3575

Timeline

Report Date

09/24/2025

Recall Initiated

08/06/2025

Classification Date

09/12/2025

Termination Date

02/19/2026

Source: U.S. Food & Drug Administration (FDA) — FDA Recalls

Last updated: August 28, 2026

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