Class II · Moderate risk
GSMS Incorporated
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.
Is Niacin recalled?
Yes — there is an active recall. 18 ongoing FDA recalls mention Niacin (48 total). Check the affected lots below.
Most common reason: Sterility / contamination (23 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Niacin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Niacin recalls in 2026
2 initiated in 2026, 48 in total — newest first
Class II · Moderate risk
Niacin Extended-release Tablets
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Class II · Moderate risk
NIACIN Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Niacin Extended-release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Niacin Extended-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Niacin Extended-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
B-Complex
Presence of Particulate Matter.
Class II · Moderate risk
Thiamine/Ribofla/Niacinami/Dexpanth/Pyridox/Hydroxycobal 25mg/25mg/25mg/25mg/25mg/20mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Methion/Inosit/Choline/Cyanocobal 25mg/50mg/50mg/1mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
B-Complex + Chromic Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
Olympia Vita-Complex Thiamine HCL
Lack of assurance of sterility.
Class II · Moderate risk
Myers Cocktail
Lack of assurance of sterility.
Class II · Moderate risk
Niacin 250mg 110
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Niacinamide 100mg/Ml
Lack of Assurance of Sterility
Class II · Moderate risk
B-complex
Lack of Sterility Assurance.
Class II · Moderate risk
Myer's Cocktail
Lack of sterility assurance.
Class II · Moderate risk
Niacinamide injection
Lack of sterility assurance.
Class II · Moderate risk
Trim Complete
Lack of sterility assurance.
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