Lannett Lisdexamfetamine Capsules Recall: Failed Content Uniformity
Lannett recalls 10mg Lisdexamfetamine Dimesylate capsules due to failed content uniformity. This affects Rx-only products with specific NDC and lot numbers. Consumers should contact the manufacturer for details.
Lower-risk recall
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Contact the company
What happened, in plain English
Lannett is recalling 10 mg Lisdexamfetamine Dimesylate capsules that failed content uniformity tests. This means the product may not deliver the intended medication dose consistently, which could affect treatment effectiveness. Read more at govinfonow.com/recall/32484-lannett-lisdexamfetamine-capsules-recall-failed-content-uniformity.
Source Summary by GovInfoNow · govinfonow.com/recall/32484-lannett-lisdexamfetamine-capsules-recall-failed-content-uniformity · Updated August 18, 2026 · FDA enforcement record: FDA #D-0112-2025
Cite this page
“Lannett Lisdexamfetamine Capsules Recall: Failed Content Uniformity.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/32484-lannett-lisdexamfetamine-capsules-recall-failed-content-uniformity. Based on FDA recall #D-0112-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0112-2025%22&limit=1).
Why it’s dangerous
The capsules failed to meet uniformity standards for medication content. This could mean inconsistent dosing, potentially leading to ineffective treatment or side effects. However, the recall does not indicate immediate safety risks like injury or death.
Who’s affected
Prescription patients who have the specific lot number (23274856A) of the 100-capsule bottle. Those using the product for ADHD or binge eating disorder treatment are most at risk.
How to tell if you have this one
Check for the lot number 23274856A on the bottle. The product is a prescription-only 10 mg capsule bottle with NDC 0527-4661-37, expiring April 30, 2025.
- Brand
Lannett- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number 23274856A on the bottle label to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in 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 8 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-0112-2025 (October 25, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0112-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.