Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules 1…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Most common reason: Labeling / mix-up (8 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Lactobacillus. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Labeling: Label Mixup: LACTOBACILLUS ACIDOPHILUS, Tablet, 35 MILLION may have potentially been mislabeled as the following drug: REPAGLINIDE, Tablet, 1 mg, NDC 00169008281, Pedigree: W003924, EXP: 6/28/2014.
Labeling: Label Mixup; LACTOBACILLUS Tablet may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 65162066850, Pedigree: AD62979_1, EXP: 5/23/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD62986_1, EXP: 5/23/2014; LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg), NDC 00054002025, Pedigree: AD21790_25, EXP: 5/1/2014; OMEGA-3 FATTY ACID, Capsule, 100
Labeling:Label Mixup; LACTOBACILLUS ACIDOPHILUS Capsule may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: AD65311_1, EXP: 5/24/2014; PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: AD65457_4, EXP: 5/24/2014.
Labeling: Label Mixup; LACTOBACILLUS GG Capsule, 15 Billion Cells may be potentially mislabeled as ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: W003356, EXP: 6/19/2014; ZONISAMIDE, Capsule, 100 mg, NDC 64679099001, Pedigree: W003786, EXP: 6/27/2014; VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: W003860, EXP: 6/27/2014.
Labeling: Label Mixup; LACTOBACILLUS GG Capsule, 10 Billion Cells may be potentially mislabeled as guaiFENesin ER, Tablet, 600 mg, NDC 63824000815, Pedigree: AD21965_22, EXP: 5/1/2014.
Labeling: Label Mixup; LACTOBACILLUS GG Capsule may be potentially mislabeled as VITAMIN B COMPLEX W/C, Capsule, NDC 54629008001, Pedigree: AD39560_4, EXP: 5/13/2014; DOCUSATE SODIUM, Capsule, 50 mg, NDC 67618010060, Pedigree: AD65457_13, EXP: 5/24/2014; VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, NDC 60258016001, Pedigree: AD70655_17, EXP: 5/28/2014; TACROLIMUS, Capsule, 1 mg, NDC 00781210
Labeling: Label Mixup; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 Million CFU may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: W002694, EXP: 6/5/2014
Labeling: Label Mixup; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 Million CFU may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: AD46257_56, EXP: 5/15/2014; MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: AD30028_28, EXP: 5/7/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: AD60240_11, EXP: 5/22/2014.
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