Lannett Lisdexamfetamine Capsules 40mg Label Mix-Up Recall
Lannett recalls 40mg Lisdexamfetamine capsules due to label mix-up with 30mg strength. This could lead to incorrect dosing if taken without proper label check.
Lower-risk recall
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
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What happened, in plain English
Lannett is recalling 40mg Lisdexamfetamine Dimesylate capsules because some bottles were mislabeled as 40mg but contain 30mg. This mix-up could cause incorrect dosing if users take the capsules without checking the label. Read more at govinfonow.com/recall/31875-lannett-lisdexamfetamine-capsules-40mg-label-mix-up-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/31875-lannett-lisdexamfetamine-capsules-40mg-label-mix-up-recall · Updated August 17, 2026 · FDA enforcement record: FDA #D-0599-2025
Cite this page
“Lannett Lisdexamfetamine Capsules 40mg Label Mix-Up Recall.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31875-lannett-lisdexamfetamine-capsules-40mg-label-mix-up-recall. Based on FDA recall #D-0599-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0599-2025%22&limit=1).
Why it’s dangerous
The capsules were mislabeled as 40mg but actually contain 30mg. This could lead to incorrect dosing if users take the capsules without checking the label, potentially causing underdosing or overdosing depending on the intended dose.
Who’s affected
People who have the 40mg Lisdexamfetamine capsules with the NDC 0527-4664-37 lot number 25280726A. Those taking the medication for ADHD or binge eating disorder are most at risk of incorrect dosing.
How to tell if you have this one
Check for the NDC code 0527-4664-37 and lot number 25280726A on the bottle. The product is a 100-count bottle of Lisdexamfetamine Dimesylate Capsules, 40mg, Rx Only.
- Brand
Lannett- Category
Drug
What to do — step by step
Check Label
Verify the label on the bottle to ensure it correctly states 40mg Lisdexamfetamine Dimesylate Capsules.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0599-2025 (August 11, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0599-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.