Drugs & supplements recalls
Prescription medicines, over-the-counter products and compounded drugs withdrawn from distribution.
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Class II · 6 months ago
Apotex Corp. Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle recall: Defective container: defect in a batch of bottle caps
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
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Class II · 6 months ago
Cipla USA, Inc. Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle recall: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
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Class II · 6 months ago
Payless Compounders, LLC Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class III · 6 months ago
Island Kinetics, Inc. d.b.a. CoValence Laboratories Remedy Gel, hydrocortisone 1% recall: Subpotent Drug
Subpotent Drug
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Class II · 6 months ago
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. exchange select recall: This recall is being initiated following FDA's recommendation based
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
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Class II · 6 months ago
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. Discount Drug Mart Food Market recall: This recall is being initiated following FDA's recommendation based
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
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Class II · 6 months ago
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. MGC Health recall: This recall is being initiated following FDA's recommendation based
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
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Class II · 6 months ago
Owen Biosciences Inc. FHF Farmhouse Fresh, Midnight Clearing, Night Lotion recall: Chemical contamination: Presence of benzene
Chemical contamination: Presence of benzene
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Class II · 6 months ago
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. MGC Health recall: This recall is being initiated following FDA's recommendation based
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the…
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Class II · 6 months ago
Sun Pharmaceutical Industries Inc Fluocinonide, USP, 0.05% Cream, 30g tube recall: Failed Viscosity Specifications: Out of Specification results
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
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Class II · 6 months ago
Cipla USA, Inc. Lanreotide Injection, 120 mg*/0.5 mL recall: Lack of Assurance of Sterility: Due to an FDA observation at the contract
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
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Class II · 6 months ago
Fresenius Kabi USA, LLC 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL , 1 recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Teva Pharmaceuticals USA, Inc Isotretinoin Capsules, USP, 30 mg recall: Superpotent and Subpotent
Superpotent and Subpotent
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Class II · 6 months ago
GE Healthcare Ireland Limited GE Healthcare Omnipaque Injection, 300 mg/mL recall: Presence of particulate matter
Presence of particulate matter
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Class II · 6 months ago
Fagron Compounding Services Vancomycin HCL, 1 gram added to 250 mL recall: Lack of Assurance of Sterility; blue Break-Off-Part could detach
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
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Class II · 6 months ago
Teva Pharmaceuticals USA, Inc Isotretinoin Capsules, USP, 40 mg recall: Superpotent and Subpotent
Superpotent and Subpotent
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Class II · 6 months ago
Fresenius Kabi USA, LLC 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL 250 mL recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Fresenius Kabi USA, LLC 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Fresenius Kabi USA, LLC 0.9% Sodium Chloride Injection, USP 0.9% 50 mL recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Fagron Compounding Services norepinephrine Bitartrate recall: Lack of Assurance of Sterility; blue Break-Off-Part could detach
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
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Class II · 6 months ago
Preferred Pharmaceuticals, Inc. Artificial Tears Lubricant Eye Drops recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Viatris, Inc. Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles recall: Failed Dissolution Specifications
Failed Dissolution Specifications
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Class II · 6 months ago
Fresenius Kabi USA, LLC 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL 1 recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Fresenius Kabi USA, LLC 5% Dextrose Injection, USP 5 g per 100 mL 100 mL in a 100 mL recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility