Sun Pharmaceutical Industries has initiated a nationwide recall of 1.6 million ADHD medication pills after laboratory tests revealed alarming dissolution failures.
The pharmaceutical incident carries an estimated $1.2 million financial impact, affecting thousands of Americans dependent on lisdexamfetamine dimesylate capsules. The FDA classified this as a Class II recall, signaling potential health risks.
The Medication Under Scrutiny
Lisdexamfetamine dimesylate is the generic version of Vyvanse, one of America’s most prescribed ADHD medications. Over nine million prescriptions were dispensed in 2023 alone.
The medication treats attention deficit hyperactivity disorder in patients aged six and older by increasing attention and decreasing impulsiveness. It’s also approved for treating moderate to severe binge eating disorder in adults.
What Went Wrong in the Lab
The pills failed critical dissolution specifications during 12-month stability testing at controlled conditions. Laboratory tests revealed the capsules didn’t break down properly when exposed to standard storage environments of 25°C and 60% relative humidity.
This failure means patients may not receive the full therapeutic dose when taking the medication, potentially leaving ADHD symptoms uncontrolled.
The $1.2M Financial Blow
The recall’s financial impact extends beyond the $1.2 million in pulled inventory. Sun Pharmaceutical faces refund obligations, replacement costs, and potential loss of market share in a competitive generic drug market.
The timing couldn’t be worse, occurring amid ongoing ADHD medication shortages that have plagued the industry since 2022.
Scale of the Recall
The recall encompasses 1.6 million pills across multiple dosage strengths from 10mg to 70mg. Affected lots were distributed nationwide through pharmacies between February and June 2025, reaching consumers across all 50 states.
The recall affects 100-count bottles with specific lot numbers and expiration dates extending into 2026.
FDA’s Class II Warning
The FDA’s Class II classification indicates the medication may cause temporary or medically reversible health consequences, though serious harm is unlikely.
However, officials warn that reduced medication effectiveness could lead to significant disruptions in patients’ daily functioning, academic performance, and workplace productivity. The classification requires immediate action from pharmacies and distributors.
Manufacturer Details
OHM Laboratories in New Jersey manufactured the defective capsules, distributed by Sun Pharmaceutical Industries’ U.S. division. This isn’t the company’s first recall—Sun Pharma recalled over 5,400 bottles in July 2025 for similar dissolution failures.
The repeated issue raises concerns about quality control measures at the manufacturing facility.
How to Check Your Medication
Patients should examine their prescription bottles for specific lot numbers: AD42468, AD48705, AD42469, AD48707, AD42470, AD48708, AD48709, AD50894, AD48710, AD50895, AD48711, AD50896, AD48712, and AD50898.
Verify the expiration dates range from February 2026 through May 2026. Contact your pharmacy immediately if your medication is from a recalled lot.
Critical Patient Warning
Medical experts strongly advise against stopping ADHD medication abruptly, even if it’s part of the recall. Sudden discontinuation can trigger withdrawal symptoms, including extreme fatigue, severe depression, and intense ADHD symptom rebound.
Continue taking your prescribed medication while arranging replacement through your pharmacy or healthcare provider.
The Broader ADHD Crisis
This recall compounds America’s ongoing ADHD medication shortage that began in October 2022.
Multiple medications, including Adderall, Vyvanse, and Concerta, have faced persistent supply disruptions due to manufacturing issues, DEA production quotas, and surging demand. Only eight percent of UK patients reported uninterrupted medication access in recent surveys.
Patient Impact Stories
Individuals with ADHD report devastating consequences from medication shortages and recalls.
Reddit forums document stories of patients calling 13 pharmacies to find their medication, skipping doses to conserve supplies, and experiencing job loss due to untreated symptoms. The recall adds another obstacle to an already complex medical landscape for ADHD patients.
The Dissolution Problem Explained
Dissolution testing measures how quickly a pill breaks down when swallowed, ensuring the active ingredient reaches the bloodstream at the expected rate of absorption.
When pills fail dissolution specs, patients may receive subtherapeutic doses, rendering treatment ineffective. The same issue led to recent recalls of atorvastatin (Lipitor), affecting over 141,000 bottles.
Previous Generic Vyvanse Concerns
Since the FDA approval of generic lisdexamfetamine in 2023, multiple manufacturers have issued recalls. Lannett recalled products in December 2024 due to failed content uniformity, meaning some pills contained inconsistent doses.
Patient complaints about generic effectiveness have circulated widely, with some reporting their ADHD symptoms returned after switching from brand-name Vyvanse.
DEA Production Constraints
As a Schedule II controlled substance, lisdexamfetamine production is strictly regulated by the Drug Enforcement Administration.
The DEA increased production quotas by 24% in September 2024 to address shortages. However, manufacturers still face quarterly quota applications and monthly reporting requirements that can limit supply flexibility during crises like recalls.
What Pharmacies Are Doing
Pharmacies have been instructed to immediately remove affected medications from shelves and notify patients who received recalled lots.
Many are struggling to source replacement medications from different manufacturers amid existing supply constraints. Patients may experience delays obtaining refills as pharmacies navigate inventory shortages and distributor allocation limits.
Alternative Treatment Options
Healthcare providers recommend patients discuss alternative ADHD medications if replacements are unavailable.
Options include different formulations of lisdexamfetamine from unaffected manufacturers, other stimulants like methylphenidate, or non-stimulant options such as atomoxetine or guanfacine. Any medication switch requires medical supervision to ensure proper dosing and effectiveness.
The Recall Process
Sun Pharmaceutical initiated voluntary recalls between October 28-30, 2025, for multiple lots.
The company sent overnight notification letters to wholesale distributors, who then alerted retail pharmacies. Patients can return affected medications to their pharmacy for full refunds or replacement from non-recalled manufacturers. The process is handled at no cost to consumers.
Quality Control Questions
This repeat recall from the same manufacturing facility raises significant concerns about quality control. In July 2025, Sun Pharma recalled products that failed dissolution tests at the nine-month stability mark; these new recalls failed at 12 months.
Experts question whether manufacturers adequately monitor the quality of generic drugs and whether FDA oversight is sufficient.
Long-term Supply Implications
The recall removes a significant amount of supply from an already constrained market at a critical time. With over nine million lisdexamfetamine prescriptions dispensed annually, the 1.6 million recalled pills represent a substantial gap.
Industry analysts worry that this could trigger panic stockpiling behavior, further destabilizing supply chains that are already weakened by years of shortages.
What Happens Next
The FDA continues investigating the root cause of dissolution failures at OHM Laboratories’ facility. Patients should monitor the FDA enforcement reports page for updates and additional recalled lots.
Healthcare advocacy groups call for stronger quality standards for generic controlled substances and more transparent communication during shortages. Contact your doctor immediately if you experience worsening ADHD symptoms.