Official recall notice
FDA DrugClass IINotable
FDA Recall: GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured
- Recall date
- 2026-06-17
- Category
- Drug
- FDA class
- Class II
Why it was recalled
Hazard
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.
Recommended action
What to do
2,961 bottles
Product description
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.