Class II · Moderate risk
Methyl B12 1000mcg/Ml/Pyridoxine 100mg W/Pres.
Lack of Assurance of Sterility
Is Pyridoxine recalled?
Yes — there is an active recall. 20 ongoing FDA recalls mention Pyridoxine (72 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Pyridoxine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Pyridoxine recalls on record
none so far in 2026; 72 on record, newest first
Class I · High risk
Vitamin Supplement
Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).
Class II · Moderate risk
Pyridoxine B6 100mg Inj
Lack of Assurance of Sterility
Class II · Moderate risk
Pyridoxine Injection
Lack of Assurance of Sterility
Class II · Moderate risk
LIPO B STERILE INJECTION 10 mL
Subpotent Drug: trace amounts of methylcobalamin in compounded drug.
Class II · Moderate risk
Pyridoxine HCL
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Pyridoxine Hydrochloride 100 mg/ml Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Pyridoxine 100 mg/1 mL Syrup
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Pyridoxine HCL
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Vitamin B6 Pyridoxine HCL for Injection USP
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Class II · Moderate risk
Pyridoxine HCL
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Pyridoxine
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Pyridoxine HCL 100 mg/mL NS
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Class II · Moderate risk
Pyridoxine HCL P/F 100 Mg/Ml Injectable
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Pyridoxine HCL
Labeling: Label Mixup: PYRIDOXINE HCL, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00536355601, Pedigree: AD73627_29, EXP: 5/30/2014; COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: W003871, EXP: 6/27/2014; VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 0 mg, NDC 40985022251, Pedigree: AD76686_1, EXP: 5/31/201
Class II · Moderate risk
Pyridoxine HCL
Labeling: Label Mixup: PYRIDOXINE HCL, Tablet, 50 mg may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS GG, Capsule, 15 Billion Cells, NDC 49100036374, Pedigree: W003787, EXP: 6/27/2014; LEVOTHYROXINE/ LIOTHYRONINE, Tablet, 19 mcg/4.5 mcg, NDC 42192032901, Pedigree: AD30197_19, EXP: 3/31/2014; CALCIUM/ CHOLECALCIFEROL/ SODIUM, Tablet, 600 mg/400 units/5 mg, NDC 00
Class II · Moderate risk
Pyridoxine HCL
Labeling: Label Mixup: PYRIDOXINE HCL, Tablet, 25 mg may have potentially been mislabeled as the following drug: TORSEMIDE, Tablet, 10 mg, NDC 50111091601, Pedigree: AD30197_25, EXP: 5/9/2014.
Class II · Moderate risk
PYRIDOXINE HCL Tablet
Labeling: Label Mixup; PYRIDOXINE HCL Tablet, 50 mg may be potentially mislabeled as CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca), NDC 00904506260, Pedigree: W002699, EXP: 6/5/2014; MULTIVITAMIN/MULTIMINERAL W/IRON, Chew Tablet, NDC 00536781601, Pedigree: W003018, EXP: 6/12/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W003705, EXP: 6/25/2014; LACTASE ENZYME, Tab
Class II · Moderate risk
Pyridoxine HCL
Labeling: Label Mixup: PYRIDOXINE HCL, Tablet, 50 mg may have potentially been mislabeled as one of the following drugs: MELATONIN, Tablet, 1 mg, NDC 04746900466, Pedigree: AD21846_17, EXP: 5/1/2014; METHOCARBAMOL, Tablet, 500 mg, NDC 00143129001, Pedigree: AD46312_28, EXP: 5/16/2014; LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00074929690, Pedigree: AD22865_16, EXP: 5/2/2014; RILUZOLE, Tablet,
Class II · Moderate risk
Pyridoxine 100mg/ml Inj MDV
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Pyridoxine Hydrochloride Injection
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Class II · Moderate risk
Pyridoxine 100mg/Ml Injectable 150 Ml 180 Ml 300 Ml 360 Ml 450 Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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