Class III U.S. Food and Drug Administration

Hi-Tech Pharmaceuticals Inc. Hi-Tech Pharmaceuticals Fish OIL Heart AND Brain Health recall: Unapproved Drug Claims

Recall published 1+ years ago

Unapproved Drug Claims.

The hazard: Mislabelling or misbranding

The product and the packaging do not match. For most people that is an annoyance; for anyone reading the label for a medical reason it is a genuine risk.

What the notice says: Unapproved Drug Claims.

Why it matters: The product carries the wrong label, the wrong lid or the wrong packaging. The food inside is generally fine; the problem is that the package describes something else, which defeats anyone relying on it.

Symptoms and when to call a doctor

There is no illness associated with mislabelling itself. The exception is where the undeclared contents include an allergen, in which case treat it as an allergen recall and watch for the reaction that person normally has.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
H-0589-2025
Published
September 24, 2025
Risk level
Class III
Status
Terminated
Issued by
U.S. Food and Drug Administration
Brand
Hi-Tech Pharmaceuticals Inc.
Product type
Seafood
Units affected
85,950 units total
Distribution
Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Guam, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming
Made in
United States
Lot / code info
Lot 517120551 Exp Date 04/30
UPC codes
811836025859

Products covered by this recall

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

Check your product

The notice names 6 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 811836025859

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 30 — 85
  • 950 units total

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 04
  • 30 — 85
  • 950 units total

Codes are lifted verbatim from the FDA — Food & cosmetics enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Mislabelled

Hi-Tech Pharmaceuticals Inc. — The product and the packaging do not match. For most people that is an annoyance; for anyone reading the label for a medical reason it is a genuine risk.

  1. Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.
  2. Keep a photo of the mismatched label, which makes the refund conversation much shorter.
  3. Check the lot code on your pack — these mix-ups are usually confined to a short production window.
  4. If the undeclared contents include an allergen, treat it as an allergen recall and stop serving it to anyone affected.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Company contact: Hi-Tech Pharmaceuticals Inc. — 6015 Unity Dr Ste B, Norcross, GA, 30071-3575

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Food & cosmetics enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Hi-Tech Pharmaceuticals Inc. seafood recalled?

Unapproved Drug Claims. Unapproved Drug Claims.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 811836025859; lot code 30 — 85, 950 units total; best-by date 04 or 30 — 85. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.

Can I get my money back?

A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.

Which states were affected?

The notice lists Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Guam, Hawaii, Iowa and others.

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