CLASS II Drug recall · Reported 3 Sep 2025 · FDA Enforcement Report
Lisdexamfetamine Dimesylate Capsules, 40 mg recalled by Lannett Company
Lannett Company is recalling Lisdexamfetamine Dimesylate Capsules, 40 mg, distributed nationwide in the US. The recall was initiated on 11 Aug 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0599-2025
- FDA event ID
- 97397
- Recalling firm
- Lannett Company, Seymour, IN
- Manufacturer
- Lannett Company, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Aug 2025
- FDA classified
- 25 Aug 2025
- Reported
- 3 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- ADHD Medication
Timeline
| 11 Aug 2025 | Recall initiated by company | |
| 25 Aug 2025 | Classified by FDA | +14 days |
| 3 Sep 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37
Where it was distributed
Nationwide within the USA
Questions about this recall
Is Lisdexamfetamine Dimesylate Capsules, 40 mg recalled?
Yes. Lannett Company recalled Lisdexamfetamine Dimesylate Capsules, 40 mg on 11 Aug 2025. The recall is Class II and its status is Terminated. Recall number D-0599-2025.
Why was it recalled?
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Which lots are affected?
Lot #: 25280726A, Exp. Date 03/2027
Where was it sold?
Nationwide within the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Lannett Company
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dextroamphetamine Saccharate recalled by Lannett CompanyDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Lannett Company | Packaging Defects | Nationwide |
| Drug | CLASS II | Niacin Extended-release Tablets, USP, 1,000 mg recalledNiacin | Lannett Company | Potency & Assay | Nationwide |
| Drug | CLASS III | Primidone Tablets USP, 250mg recalled by Lannett CompanyPrimidone | Lannett Company | Other | Nationwide |
| Drug | CLASS II | Niacin Extended-release Tablets, USP, 1,000 mg recalledNiacin | Lannett Company | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalledDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Lannett Company | Other | OH |
Other Lisdexamfetamine Di recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lisdexamfetamine Dimesylate Capsules, 30 mg, CII recalledLisdexamfetamine Dimesylate | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Lisdexamfetamine Dimesylate Capsules, 40 mg, CII recalledLisdexamfetamine Dimesylate | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Lisdexamfetamine Dimesylate Capsules, 10 mg, CII recalledLisdexamfetamine Dimesylate | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Lisdexamfetamine Dimesylate Capsules, 20 mg, CII recalledLisdexamfetamine Dimesylate | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Lisdexamfetamine Dimesylate Capsules, 70 mg, CII recalledLisdexamfetamine Dimesylate | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |