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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Lisdexamfetamine Dimesylate Capsules Recalled for Label Mix-up

Agency Publication Date: August 25, 2025
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Summary

Lannett Company Inc. is recalling 8,544 bottles of Lisdexamfetamine Dimesylate Capsules, 40 mg (the generic equivalent of Vyvanse). The recall was issued because bottles labeled as containing 40 mg capsules actually contained 30 mg capsules. Consumers should check their 100-count bottles for specific lot numbers and expiration dates to ensure they are receiving the correct dosage. If you have this medication, contact your healthcare provider or pharmacist regarding the dosage discrepancy.

Risk

Patients may receive a lower dose of medication than prescribed (30 mg instead of 40 mg), which could result in inadequate treatment and the return of symptoms for their underlying condition. No incidents or injuries have been reported to date.

What You Should Do

  1. This recall affects 100-count bottles of Lisdexamfetamine Dimesylate Capsules, 40 mg, distributed by Lannett Company, Inc. with NDC 0527-4664-37.
  2. Identify your medication by checking the label for lot number 25280726A and an expiration date of 03/2027.
  3. If you have health concerns, contact your healthcare provider or pharmacist for guidance. Return any unused product to the place of purchase for a refund, throw it away, or contact Lannett Company Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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 (40 mg)
Variants: 40 mg, 100-count bottles
Lot Numbers:
25280726A (Exp 03/2027)
NDC:
0527-4664-37

A bottle labeled as 40mg contained 30mg capsules.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97397
Status: Resolved
Manufacturer: Lannett Company Inc.
Sold By: Pharmacies; Drug stores
Manufactured In: United States
Units Affected: 8544 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 ยท 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.