Generic Vyvanse Injury Lawsuit Lawyers

Sun Pharma Recalls Popular ADHD Medication After Failing Dissolution Tests and What You Need to Know If You or a Loved One Was Affected

Millions of patients across the United States rely on lisdexamfetamine dimesylate capsules—the generic version of Vyvanse—to manage symptoms of attention-deficit/hyperactivity disorder (ADHD). The medication is often prescribed to children, teens, and adults to improve concentration, reduce impulsive behavior, and support daily functioning. In 2023 alone, more than nine million prescriptions for the generic were dispensed.

However, recent enforcement records from the Food and Drug Administration (FDA) reveal that multiple lots of this medication are being recalled after failing critical quality control testing. According to the FDA, Sun Pharmaceutical Industries, Inc. has initiated a voluntary recall of seven capsule strengths after discovering the drugs do not dissolve properly.

The defective capsules could result in ineffective treatment or unexpected side effects, especially for patients with tightly managed dosage schedules. The recall has been designated Class II, meaning the drugs may cause temporary or medically reversible health consequences. Given the widespread use of this medication, the number of affected patients may be significant—and so are the legal implications.

What Prompted the Recall?

On October 28, 2025, Sun Pharma issued a voluntary recall for seven capsule strengths of lisdexamfetamine dimesylate. The recall was classified by the FDA as Class II just two days later.

According to testing records, the issue lies in the medication’s failure to dissolve properly—a crucial factor for stimulant medications, which must be absorbed at predictable rates to regulate focus and behavior.

The FDA’s recall notice confirmed that affected lots may fail to deliver the intended therapeutic effect, potentially causing symptoms to return or worsen. These consequences can be particularly dangerous for patients in school, at work, or managing other health conditions.

Despite the severity of the issue, Sun Pharma did not release a public statement or press release to warn consumers, and the FDA did not offer detailed guidance for patients who may have already taken the recalled medication.

Recalled Capsule Lots and Strengths

The affected products include 100-count bottles across seven strengths:

• 10 mg: AD42468, AD48705 (Exp: 2/28/26, 4/30/26)
• 20 mg: AD42469, AD48707 (Exp: 2/28/26, 4/30/26)
• 30 mg: AD42470, AD48708 (Exp: 2/28/26, 4/30/26)
• 40 mg: AD48709, AD50894 (Exp: 4/30/26, 5/31/26)
• 50 mg: AD48710, AD50895 (Exp: 4/30/26, 5/31/26)
• 60 mg: AD48711, AD50896 (Exp: 4/30/26, 5/31/26)
• 70 mg: AD48712, AD50898 (Exp: 4/30/26, 5/31/26)

Patients, pharmacists, and healthcare providers are advised to check prescriptions for any of these lot numbers. The FDA suggests continuing treatment only under the direction of a physician, as abrupt discontinuation of ADHD medications can lead to withdrawal effects and sudden symptom return.

Medical Risks From Defective ADHD Medication

The danger posed by a defective ADHD medication is not limited to treatment failure. Stimulant medications like lisdexamfetamine require consistent blood levels to be effective. Poor dissolution may result in:

• Lack of symptom control (inattention, impulsivity, hyperactivity)
• Sleep disturbances
• Mood swings or behavioral issues
• Increased anxiety, depression, or aggression
• Disruption in school or work performance
• Medication withdrawal symptoms

Children and teens are particularly vulnerable to erratic dosing outcomes, which can affect academic progress, emotional regulation, and social development. Adults may suffer workplace performance issues or driving hazards linked to untreated symptoms.

Who Are the Potential Victims and Who Could Be Held Liable?

A wide range of individuals may have been harmed by the recalled lisdexamfetamine dimesylate capsules. Given the volume of prescriptions and the length of time the defective lots remained on the market, millions of patients could have unknowingly taken substandard medication.

Potential victims include:

• Children and teenagers who experienced behavioral regression, academic decline, or emotional distress due to ineffective medication.
• Adults whose job performance, driving, or daily functioning was impaired due to unregulated ADHD symptoms.
• Parents or caregivers who were misled by prescription safety and are managing the fallout from a child’s adverse effects.
• Patients hospitalized or injured due to treatment disruptions.

Potential defendants in a lawsuit may include:

• Sun Pharmaceutical Industries, Inc., for distributing medication that failed dissolution standards.
• Wholesalers and pharmacy chains that continued selling the affected lots despite FDA enforcement actions.
• Third-party manufacturers, if production defects originated at a contracted facility.

Victims may pursue product liability, failure to warn, negligence, or consumer protection claims, depending on their jurisdiction. Where injuries are severe, claims may also include pain and suffering, lost wages, or long-term care costs.

What Should Patients Do If They Took Recalled Medication?

The FDA has not issued detailed next steps for patients, but generally advises not to stop medications without consulting a healthcare provider. Patients should:

1. Check their prescription bottles for lot numbers listed in the recall.
2. Contact their pharmacy for information about affected inventory.
3. Speak with their prescribing physician immediately if they experience any unusual symptoms or a return of ADHD symptoms.
4. Keep records of any medical issues, prescription labels, and dates of medication use.

Those who have experienced negative health outcomes after taking the recalled product should consider legal consultation to protect their rights.

Legal Rights and Compensation for Affected Patients

Individuals harmed by defective or substandard medication have legal remedies available. Affected patients may be eligible to file a lawsuit seeking compensation for:

• Medical expenses (hospital visits, specialist care, medication changes)
• Missed school or work due to symptom relapse or complications
• Emotional distress or psychological harm
• Permanent or long-term impairment
• Costs of switching medications and additional care

Legal action also serves an important public health role by holding companies accountable and preventing future harm.

ADHD Drug Recall Lawsuit FAQs

What is lisdexamfetamine dimesylate and why was it recalled?

It’s the generic version of Vyvanse, a commonly prescribed stimulant for ADHD. It was recalled because multiple lots failed to dissolve properly, which can reduce effectiveness and cause unpredictable health outcomes.

How do I know if I took the recalled medication?

Check the lot number and expiration date printed on your prescription bottle. Compare it against the list published by the FDA and Sun Pharma.

What symptoms could result from the defective capsules?

Possible effects include a return of ADHD symptoms, emotional instability, sleep problems, and poor focus. In some patients, abrupt changes in effectiveness could lead to accidents, withdrawal symptoms, or psychiatric complications.

Can I file a lawsuit even if I didn’t go to the hospital?

Yes. If you suffered emotional, academic, occupational, or medical harm due to the defective drug, you may have a valid claim—even without hospitalization.

Who can be held responsible?

The distributor, Sun Pharmaceutical Industries, Inc., along with any third-party manufacturers or distributors involved in producing or supplying the defective lots.

What kind of compensation can victims seek?

Compensation may include medical costs, therapy expenses, pain and suffering, lost income, and damages for long-term complications.

What if my child was harmed by this medication?

Parents may bring claims on behalf of their minor children if they suffered harm due to defective medication. Claims can include emotional distress, medical bills, educational setbacks, and related expenses.

Contact Parker Waichman LLP For A Free Case Review

If you or a loved one was harmed after taking a recalled ADHD medication, you may be eligible for financial compensation. Parker Waichman LLP is a national personal injury law firm investigating claims related to the lisdexamfetamine dimesylate recall.

Our attorneys are standing by to help families pursue justice after preventable medication harm. Call 1-800-YOUR-LAWYER (1-800-968-7529) for a free consultation today. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.