Class III U.S. Food and Drug Administration

Hi-Tech Pharmaceuticals Inc. Hi-Tech Pharmaceuticals Adderex XR Strongest Focusing recall: Unapproved Drug Claims and Misbranded

Recall published 1+ years ago

Unapproved Drug Claims and Misbranded.

The hazard: Mislabelling or misbranding

Misbranding prompted this recall. The agency treats a label that misstates the contents as seriously as it treats contamination, because people act on labels.

What the notice says: Unapproved Drug Claims and Misbranded.

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-0587-2025
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
Other food products
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 303120691 Exp Date 05/28
UPC codes
811836026917

Products covered by this recall

HI-TECH PHARMACEUTICALS ADDEREX XR STRONGEST FOCUSING AID WITHOUT A PRESECRIPTION! HELPS ADULTS MAINTAIN CONCENTRATION & IMPROVE PRODUCTIVITY! 30 TABLETS UPC 8 11836 02691 7 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071

Check your product

The notice names 7 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.

  • 811836026917

Lot or batch code

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

  • 28 — 85
  • 950 units total

Best-by / use-by date

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

  • 05
  • 28 — 85
  • 950 units total

Model or item number

On the rating label, the box or the instruction sheet.

  • IVITY

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. — Misbranding prompted this recall. The agency treats a label that misstates the contents as seriously as it treats contamination, because people act on labels.

  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. If the undeclared contents include an allergen, treat it as an allergen recall and stop serving it to anyone affected.
  3. Return it for a refund; a mislabelled pack is returnable whether or not it is edible for your household.
  4. Keep a photo of the mismatched label, which makes the refund conversation much shorter.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

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. other food products recalled?

Unapproved Drug Claims and Misbranded. Unapproved Drug Claims and Misbranded.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 811836026917; lot code 28 — 85, 950 units total; best-by date 05 or 28 — 85; model number IVITY. 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?

Claim the refund at the store first; it is the fastest route and needs the least paperwork.

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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