HIGH

Lannett Recalls Lisdexamfetamine Capsules Over Labeling Error

Lannett Company recalled 8,544 bottles of Lisdexamfetamine Dimesylate Capsules on August 11, 2025. The recall occurred due to a labeling mix-up where 40 mg capsules were mislabeled as 30 mg. This issue poses a high risk to consumers who may receive incorrect dosages.

Quick Facts at a Glance

Recall Date
August 11, 2025
Hazard Level
HIGH
Brands
Lisdexamfetamine Dimesylate, Lannett Company
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Lannett Company Inc. or your healthcare provider for guidance. Notification method: Letter

Product Details

The recall involves Lisdexamfetamine Dimesylate Capsules, 40 mg, packaged in 100-count bottles. The affected lot number is 25280726A, with an expiration date of March 2027. These products were distributed nationwide.

The Hazard

The labeling error could lead to patients receiving an incorrect dosage of the medication. This poses a significant risk, especially in individuals relying on specific dosages for ADHD treatment.

Reported Incidents

Currently, no injuries or incidents have been reported as a direct result of this labeling error. However, the potential for serious health consequences exists if patients consume the incorrect dosage.

What to Do

Consumers should immediately stop using the recalled product. Contact Lannett Company for guidance and further instructions regarding returns and refunds.

Contact Information

For more information, call Lannett Company at 1-800-XXX-XXXX or visit their website. Additional details are available on the FDA recall page.

Key Facts

  • Recall date: August 11, 2025
  • Quantity recalled: 8,544 bottles
  • Labeling mix-up identified
  • Risk of incorrect dosage for patients
  • Contact Lannett for further instructions

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot #: 25280726A
Exp. Date 03/2027
UPC Codes
0527-4661
0527-4662
0527-4663
+11 more
Affected States
ALL
Report Date
September 3, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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