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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 Failed Dissolution

Agency Publication Date: July 11, 2025
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Summary

Sun Pharmaceutical Industries Inc is recalling 5,448 bottles of Lisdexamfetamine Dimesylate (60 mg), a prescription medication used to treat ADHD and Binge Eating Disorder. The recall was issued because the capsules failed dissolution testing during stability analysis, meaning the medication may not dissolve or release properly in the body. If you are taking this medication, please contact your doctor or pharmacist to discuss your treatment.

Risk

When a drug fails dissolution specifications, it may not be absorbed at the intended rate or amount, which can lead to inconsistent treatment of the patient's condition or reduced effectiveness of the medication. No reports of adverse events or injuries have been noted in the recall data.

What You Should Do

  1. The recalled product is Lisdexamfetamine Dimesylate Capsules, 60 mg, sold in 100-count bottles with NDC 57664-051-88 and lot number AD42648 (Expiration: 02/28/2026).
  2. 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 Sun Pharmaceutical Industries Inc for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) 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 (100-count bottle)
Variants: 60 mg, CII, Rx only
Lot Numbers:
AD42648 (Exp 02/28/2026)
NDC:
57664-051-88

Manufactured by: OHM Laboratories, New Brunswick, NJ 08901; Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512; Recall #: D-0516-2025.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97092
Status: Active
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Sold By: distributors; pharmacies
Manufactured In: United States
Units Affected: 5,448 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.