Summary
A nationwide recall has been announced for certain lots of Lisdexamfetamine dimesylate capsules by Sun Pharmaceutical Industries due to them not dissolving as expected. The U.S. Food and Drug Administration (FDA) has classified this recall as Class II, indicating potential temporary or reversible health risks but not serious harm.
Key Facts
- Lisdexamfetamine dimesylate is a medication often used to treat ADHD in people over 6 years old.
- The recall affects multiple lots of the drug distributed in 100-count bottles, including various dosages.
- The FDA classified the recall as Class II, meaning it could cause temporary health issues, but serious harm is unlikely.
- The recalled medication failed laboratory dissolution tests, which could impact its effectiveness.
- Sun Pharmaceutical Industries started the recall on October 28, 2023.
- Over 9 million prescriptions of this medication were issued in the U.S. in 2023.
- Patients with affected bottles should contact their healthcare providers for advice on alternatives or refunds.
