Class II U.S. Food and Drug Administration

Lannett Company Inc. Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles recall: Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate

Recall published 1+ years ago

Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.

The hazard: Drug safety concern

A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.

What the notice says: Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Recall number
D-0599-2025
Published
September 3, 2025
Risk level
Class II
Status
Terminated
Issued by
U.S. Food and Drug Administration
Brand
Lannett Company Inc.
Product type
Prescription & OTC drugs
Units affected
8544 bottles
Distribution
Nationwide
Made in
United States
Lot / code info
Lot #: 25280726A, Exp. Date 03/2027

Products covered by this recall

Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37

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.

Lot or batch code

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

  • 25280726A
  • 2027 — 8544 bottles

Best-by / use-by date

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

  • 03
  • 2027 — 8544 bottles

NDC number

On the carton and again on the bottle or blister label.

  • 0527-4664-37

Package size

Match the net weight or the piece count on the front of the pack.

  • 40 mg
  • 100 count

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

What to do about Drug safety

Lannett Company Inc. — A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.

  1. Check the lot number on your pack against the codes listed above.
  2. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.
  3. Ask the dispensing pharmacy for a replacement from an unaffected lot.
  4. Keep the carton; the lot number is often printed only on the outer pack.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: Lannett Company Inc. — 1101 C Ave W, Seymour, IN, 47274-3342

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 — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Lannett Company Inc. prescription & otc drugs recalled?

Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg. Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 25280726A, 2027 — 8544 bottles; best-by date 03 or 2027 — 8544 bottles. 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?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Where was the recalled product sold?

It was distributed nationwide.

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