Class II · Moderate risk
Vitamin B Complex
Lack of sterility assurance.
Is Niacin recalled?
Yes — there is an active recall. 18 ongoing FDA recalls mention Niacin (48 total). Check the affected lots below.
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 on record
none so far in 2026; 48 on record, newest first
Class II · Moderate risk
Metronidazole 1% Gel
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Rosacea Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Acne Solution
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Lipotropic with MIC
Lack of Assurance of Sterility
Class II · Moderate risk
Lipotropic
Lack of Assurance of Sterility
Class II · Moderate risk
Lipo-C (Methionine 25 mg/Inositol 50 mg/Choline Chloride 50 mg/Carnitine (L)
Lack of Assurance of Sterility
Class II · Moderate risk
IV Cocktail #2
Lack of Assurance of Sterility
Class II · Moderate risk
Infuvite IV
Lack of Assurance of Sterility
Class II · Moderate risk
B-Complex (30 Ml)
Lack of Assurance of Sterility
Class II · Moderate risk
Amino Energy Cocktail
Lack of Assurance of Sterility
Class II · Moderate risk
Niacinamide 100 Mg/Ml
Lack of Assurance of Sterility
Class II · Moderate risk
Lipotropic Gold
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Niacin Extended Release Tablets
Failed Tablet/Capsule Specifications: There is a potential for broken tablets.
Class II · Moderate risk
Niacin Tr
Labeling: Label Mixup: NIACIN TR, Tablet, 1000 mg may have potentially been mislabeled as the following drug: NIACIN TR, Tablet, 750 mg, NDC 00536703301, Pedigree: AD46414_56, EXP: 5/16/2014.
Class II · Moderate risk
Niacin Tr
Labeling: Label Mixup: NIACIN TR, Tablet, 750 mg may have potentially been mislabeled as the following drug: NORTRIPTYLINE HCL, Capsule, 50 mg, NDC 00093081201, Pedigree: AD46414_47, EXP: 5/16/2014.
Class II · Moderate risk
Niacin ER
Labeling: Label Mixup: NIACIN ER, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: CHOLECALCIFEROL, Capsule, 50000 units, NDC 53191036201, Pedigree: AD60268_4, EXP: 5/22/2014; METAXALONE, Tablet, 800 mg, NDC 64720032110, Pedigree: W003738, EXP: 6/26/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: W003716, EXP: 6/26/2014; C
Class II · Moderate risk
Niacin Tr
Labeling: Label Mixup; NIACIN TR, Tablet, 250 mg may be potentially mislabeled as SOLIFENACIN SUCCINATE, Tablet, 5 mg, NDC 51248015001, Pedigree: W003755, EXP: 6/26/2014.
Class II · Moderate risk
Niacin Tr
Labeling: Label Mixup; NIACIN TR, Tablet, 500 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: W002968, EXP: 6/11/2014.
Class II · Moderate risk
Niacin
Labeling: Label Mixup: NIACIN, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: NAPROXEN, Tablet, 500 mg, NDC 53746019001, Pedigree: AD54516_1, EXP: 5/20/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: W002920, EXP: 6/10/2014.
Class II · Moderate risk
Niacin
Labeling: Label Mixup: NIACIN, Tablet, 100 mg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000815, Pedigree: W002660, EXP: 6/5/2014.
Class II · Moderate risk
Niacin Tr
Labeling: Label Mixup: NIACIN TR, Capsule, 500 mg may have potentially been mislabeled as one of the following drugs: PERPHENAZINE, Tablet, 16 mg, NDC 00603506321, Pedigree: AD46265_49, EXP: 5/15/2014; MELATONIN, Tablet, 1 mg, NDC 47469000466, Pedigree: AD60240_14, EXP: 5/22/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: W002693, EXP: 6/5/2014; GLUCOSAMIN
Class II · Moderate risk
Niacin Tr
Labeling: Label Mixup: NIACIN TR, Capsule, 250 mg may have potentially been mislabeled as the following drug: METHYLERGONOVINE MALEATE, Tablet, 0.2 mg, NDC 43386014028, Pedigree: W003477, EXP: 6/20/2014.
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