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Niacin

FDA recalls

5 rows

DateCompany and reasonClass
May 28, 2026Golden State Medical Supply Inc.
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
Class II · Ongoing
May 26, 2026Lannett Company Inc.
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Class II · Ongoing
Oct 19, 2025Golden State Medical Supply Inc.
Failed Dissolution Specifications
Class II · Ongoing
Oct 9, 2025Lannett Company Inc.
Failed Dissolution Specifications
Class II · Ongoing
Jan 17, 2024Sun Pharmaceutical Industries Inc
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Completed

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).