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Nationwide Recall Alert: ADHD Drug May Not Dissolve Correctly
The FDA designated the recall as Class II risk after tests showed the drug did not dissolve properly, potentially reducing effectiveness for millions of ADHD patients.
- On Nov. 10, 2025, Sun Pharmaceutical Industries voluntarily recalled several lots of lisdexamfetamine dimesylate capsules nationwide, and the U.S. Food and Drug Administration classified it as a Class II recall.
- Laboratory dissolution testing found affected lots failed to dissolve as expected, which could reduce dose delivery and limit therapeutic benefit for patients prescribed lisdexamfetamine dimesylate.
- The recall covers 100-count bottles across a range of doses, with affected lot numbers and expiration dates listed by the company; the U.S. Food and Drug Administration enforcement reports page provides a full list.
- Patients prescribed lisdexamfetamine dimesylate should not stop taking medication suddenly and must contact their prescribing physicians or pharmacies immediately for safe replacement instructions.
- Lisdexamfetamine dimesylate is widely used, with over nine million prescriptions dispensed in 2023, so millions of Americans may face dosing or effectiveness concerns due to the dissolution issue.
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18 Articles
18 Articles
The Norfolk Daily News+12 Reposted by 12 other sources
Nationwide Recall Alert: ADHD Drug May Not Dissolve Correctly
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Coverage Details
Total News Sources18
Leaning Left4Leaning Right1Center5Last UpdatedBias Distribution50% Center
Bias Distribution
- 50% of the sources are Center
50% Center
L 40%
C 50%
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