Medications & Supplements/Prescription Drugs

Lannett Lisdexamfetamine Capsules Recalled for Content Uniformity Failure

Agency Publication Date: December 5, 2024

Summary

Lannett Company Inc. has recalled 1,608 bottles of Lisdexamfetamine Dimesylate Capsules (10 mg), a prescription medication used to treat ADHD and Binge Eating Disorder. The recall was issued because testing showed the medication failed to meet "content uniformity" standards, meaning some capsules may contain more or less of the active ingredient than intended. The affected product is packaged in bottles of 100 capsules and was distributed nationwide in the United States.

Risk

Inconsistent levels of the active ingredient can cause the medication to be less effective or potentially lead to side effects if a capsule contains more medicine than the prescribed dose.

What You Should Do

This recall affects 100-count bottles of generic Lisdexamfetamine Dimesylate Capsules (10 mg) distributed by Lannett Company.
Check your medication bottle for NDC 0527-4661-37 and Lot 23274856A with an expiration date of 04/30/2025.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Lisdexamfetamine Dimesylate Capsules (10 mg)

Variants: 10 mg, 100 Capsules per bottle

Lot Numbers:

23274856A (Exp 04/30/2025)

NDC:

0527-4661-37

Recall #: D-0112-2025; Distributed by: Lannett Company, Philadelphia, PA 19136

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95630

Status: Resolved

Manufacturer: Lannett Company Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 1608 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects 100-count bottles of generic Lisdexamfetamine Dimesylate Capsules (10 mg) distributed by Lannett Company.

Check your medication bottle for NDC 0527-4661-37 and Lot 23274856A with an expiration date of 04/30/2025.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.