Last Updated on January 13, 2026 by The Health Master
Drug recall
Recently, U.S. operations of Sun Pharmaceuticals took the voluntary initiative to drug recall certain batches of its sought-after Attention Deficit Hyperactivity Disorder (ADHD) treatment, Lisdexamfetamine Dimesylate, an essential CNS stimulant drug that patients rely on.
According to the USFDA’s latest enforcement report, the primary reason for the drug recall is an inability to meet specific “dissolution specifications.”
In layman’s terms, the drug does not dissolve in the body as intended, which is critical for proper function.
From October 28 to 30, the Mumbai-based drug manufacturer ordered the drug recall in five distinct parts.
The Lisdexamfetamine Dimesylate Capsules were manufactured via contract manufacturer OHM Laboratories of New Brunswick, yet the exact amount recalled has not been disclosed.
Underlying the Issue of Quality: Dissolution Failure
The technical cause for the Lisdexamfetamine Dimesylate recall involves an “out-of-specification result observed in the dissolution test during analysis at the 12-month long-term stability station (25°C, 60% RH).”
A dissolution test is a quality control measure a manufacturer assesses to quantify how fast and how well the active pharmaceutical ingredient separates from a dosage form (tablet or capsule) in a liquid medium like those in the gastrointestinal tract.
If a tablet does not dissolve correctly, then an inappropriate therapeutic dosage is administered, and this is why this is considered a severe quality failure in ADHD medications.
Class II Drug Recall:
This voluntary action has been classified by the USFDA as a “Class II” drug recall.
- Class II drug recall meaning: The product may cause temporary or medically reversible adverse health consequences, but the likelihood of serious adverse health consequences is remote.
While patients who rely on this CNS stimulant drug may find it okay not to be actively using this product as a medical risk to permanent injury, it’s important to note that lisdexamfetamine dimesylate may not be functioning as anticipated due to this dissolution problem.
A Larger Issue
This isn’t the first time Sun Pharma has faced this particular challenge.
In July 2023, Sun Pharma initiated a drug recall of over 5,400 bottles of the same medication due to an out-of-specification result in the dissolution test noted at the nine-month stability station.
These versions were recalled at the same site (OHM Laboratories) where those in October were and were both noted as Class II actions by the USFDA.
This presents either a manufacturing concern or an ongoing challenge related to stability.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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