CLASS II Drug recall · Reported 11 Dec 2024 · FDA Enforcement Report
Lisdexamfetamine Dimesylate Capsules, 10 mg recalled by Lannett Company
Lannett is recalling Lisdexamfetamine Dimesylate Capsules, 10 mg per, distributed nationwide in the US. The recall was initiated on 25 Oct 2024 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-0112-2025
- FDA event ID
- 95630
- Recalling firm
- Lannett, Seymour, IN
- Manufacturer
- Lannett Company, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Oct 2024
- FDA classified
- 5 Dec 2024
- Reported
- 11 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- ADHD Medication
Timeline
| 25 Oct 2024 | Recall initiated by company | |
| 5 Dec 2024 | Classified by FDA | +41 days |
| 11 Dec 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Product as listed by the FDA
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Which lots are affected?
Lot: 23274856A, Exp 04/30/2025
Where was it sold?
Nationwide in 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Lisdexamfetamine Dimesylate 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 |