CLASS III Food recall · Reported 24 Sep 2025 · FDA Enforcement Report
Fish Oil Heart And Brain Health Epa/dha Omega 3 Fatty Acids recalled
Hi-Tech Pharmaceuticals is recalling Fish Oil Heart And Brain Health Epa/dha Omega 3 Fatty Acids Supports Cardiovascular, distributed in 49 states. The recall was initiated on 6 Aug 2025 and the FDA has classified it as Class III.
Check your package
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
Recall details
- Recall number
- H-0589-2025
- FDA event ID
- 97373
- Recalling firm
- Hi-Tech Pharmaceuticals, Norcross, GA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 6 Aug 2025
- FDA classified
- 12 Sep 2025
- Reported
- 24 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Hidden Drug Ingredients
- Product category
- Fish Oil
Timeline
| 6 Aug 2025 | Recall initiated by company | |
| 12 Sep 2025 | Classified by FDA | +37 days |
| 24 Sep 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Unapproved Drug Claims.
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
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
Where it was distributed
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.
AlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichigan
Questions about this recall
Why was it recalled?
Unapproved Drug Claims.
Which lots are affected?
Lot 517120551 Exp Date 04/30
Where was it sold?
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.
What should I do if I have it?
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
15 other products · FDA event 97373This product is part of a recall event; the main page for the event is Primenutrition Taurine Mental & Athletic Performance recalled.
More recalls from Hi-Tech Pharmaceuticals
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | CLASS III | Slimaglutide Revolutionary Weight Loss Aid recalledHi-tech Pharmaceuticals | Hi-Tech Pharmaceuticals | Labeling Errors | 49 states |
| Food | CLASS III | Joint-rx Dietary Supplement 600mc Helps Rebuild Cartilage recalledHi-tech Pharmaceuticals | Hi-Tech Pharmaceuticals | Hidden Drug Ingredients | 49 states |
| Food | CLASS III | Lgsciences Battle Hardener Platinum Series Complete 6 Week recalledLgsciences Battle | Hi-Tech Pharmaceuticals | Hidden Drug Ingredients | 49 states |
| Food | CLASS III | Primenutrition Phytoform Fruits & Greens Formula recalledPrimenutrition Phytoform | Hi-Tech Pharmaceuticals | Labeling Errors | 49 states |
| Food | CLASS III | Primenutrition Phytoform Fruits & Greens Formula recalledPrimenutrition Phytoform | Hi-Tech Pharmaceuticals | Labeling Errors | 49 states |
Other Fish Oil recalls
All 41| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | CLASS II | Ocular Plus with Lutein, Zeaxanthin, and Omega recalledOcular Plus | Provision Health | Undeclared Allergens | CA |
| Food | CLASS I | o Nagatoshi Large AA Brown Omega-3 1 dozen cartons o Nijiya recalled | Country Eggs | Salmonella | CA, NV |
| Food | CLASS II | Fresh Flax Oil Omega 3-6-9 Organic Flaxseed Oil recalled | Bioriginal Food & Science | Undeclared Allergens | PR |
| Food | CLASS I | Jif Creamy Omega 3 Peanut Butter recalled by The JM Smucker CompanyJif Creamy | The JM Smucker | Salmonella | 49 states |
| Food | CLASS II | Dha Omega-3 Organic Whole Milk - - Simply Balanced recalledDha Omega-3 | C & S Wholesale Grocers | Temperature Abuse | NY |