Magnesium Sulfate 50% Injectable
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Yes — there is an active recall. 21 ongoing FDA recalls mention Magnesium (165 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Magnesium. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Labeling:Label Mixup; MAGNESIUM CHLORIDE, Tablet, 64 mg may be potentially mislabeled as VITAMIN B COMPLEX W/C, Tablet, NDC 00904026013, Pedigree: AD52993_31, EXP: 5/17/2014; ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: W003526, EXP: 6/21/2014; NICOTINE POLACRILEX, LOZENGE, 2 mg, NDC 00135051001, Pedigree: W002766, EXP: 6/6/2014; THIAMINE HCL, Tablet, 100 mg, NDC 00904054460, Pedig
Labeling:Label Mixup; MAGNESIUM GLUCONATE DIHYDRATE Tablet, 500 mg (27 mg Elemental Magnesium) may be potentially mislabeled as hydrALAZINE HCl, Tablet, 100 mg, NDC 23155000401, Pedigree: AD30197_7, EXP: 5/9/2014.
Labeling: Label Mixup; MAGNESIUM GLUCONATE Tablet, 500 mg (27 mg Elem Mg) may be potentially mislabeled as FLUVASTATIN, Capsule, 20 mg, NDC 00378802077, Pedigree: W002655, EXP: 6/4/2014.
Labeling: Label Mixup; MAGNESIUM CHLORIDE DR, Tablet, 64 mg may be potentially mislabeled as SELEGILINE HCL, Capsule, 5 mg, NDC 67253070006, Pedigree: AD54549_19, EXP: 5/20/2014; PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: AD70639_10, EXP: 5/29/2014.
Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.
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.
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.
Non-Sterility; mold contamination
CGMP Deviations: this product is being recalled because an FDA inspection revealed that it was not manufactured under current good manufacturing practices.
Defective Container: Product lacks tamper evident breakaway band on cap.
Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules.
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.
Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.
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