Lisdexamfetamine Dimesylate Capsules recall
FDA recall D-0599-2025 · initiated Aug 11, 2025
Lannett Company Inc. recalled Lisdexamfetamine Dimesylate Capsules in Aug 2025 — an FDA Class II recall (D-0599-2025) because Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 8544 bottles
Details
- Product
- Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37
- Recalling company
- Lannett
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the USA
- Initiated
- Aug 11, 2025
- FDA report date
- Sep 3, 2025
Frequently asked
- Was Lisdexamfetamine Dimesylate Capsules recalled?
- Lannett Company Inc. recalled Lisdexamfetamine Dimesylate Capsules in Aug 2025 — an FDA Class II recall (D-0599-2025) because Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Lisdexamfetamine Dimesylate Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0599-2025 was: Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
- Is a recalled Lisdexamfetamine Dimesylate Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Lisdexamfetamine Dimesylate Capsules are affected?
- Distributed: Nationwide within the USA. The recall covers these lots — Lot #: 25280726A, Exp. Date 03/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0599-2025.