Drugs & supplements recalls
Prescription medicines, over-the-counter products and compounded drugs withdrawn from distribution.
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Class II · 6 months ago
Wells Pharma of Houston LLC fentaNYL Citrate Injectable Solution in 0.9% Sodium recall: cGMP deviations
cGMP deviations.
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Class II · 6 months ago
Thea Pharma, Inc. iVIZIA, Sterile Lubricant Eye Drops , 0.33 Fl oz recall: Lack of Assurance of Sterility: This recall has been initiated due to CGMP
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
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Class II · 6 months ago
Wells Pharma of Houston LLC Ketamine Hydrochloride Injectable Solution recall: cGMP deviations
cGMP deviations.
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Class II · 6 months ago
Thea Pharma, Inc. Similasan, iVIZIA, Sterile Lubricant Eye Drops , 0.33 Fl oz recall: Lack of Assurance of Sterility: This recall has been initiated due to CGMP
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
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Class II · 6 months ago
Hetero Labs Limited Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg recall: Discoloration: Firm received five (5) complaints stating
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
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Class II · 6 months ago
B Braun Medical Inc Sterile Water for Injection USP, 3000 mL bags recall: Lack of Assurance of Sterility; potential for leakage from the diaphragm port
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
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Class II · 6 months ago
B Braun Medical Inc 0.9 % Sodium Chloride Irrigation, USP, 3000 mL bags recall: Lack of Assurance of Sterility; potential for leakage from the diaphragm port
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
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Class II · 6 months ago
Teva Pharmaceuticals USA, Inc Claravis , 10 mg, Packaged as a) 100-count carton recall: Failed Impurities/Degradation Specifications: Out of specification
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
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Class II · 6 months ago
B Braun Medical Inc Lactated Ringer's Irrigation, 3000 mL bags, Sterile, Ex only recall: Lack of Assurance of Sterility; potential for leakage from the diaphragm port
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
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Class III · 6 months ago
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles recall: Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914…
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Class II · 6 months ago
Leading Pharma, LLC Furosemide Tablets, USP, 80 mg, 100 Tablets bottles recall: CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
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Class II · 6 months ago
B Braun Medical Inc Dextrose Injection USP, 70%, 2000 mL bags recall: Lack of Assurance of Sterility; potential for leakage from the diaphragm port
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
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Class II · 6 months ago
Harrow Eye LLC Freshkote Lubricant Eyedrops, Sterile, 0.33 FL OZ recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
The Harvard Drug Group LLC Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram recall: Failed Capsule Specifications: Out of specification results obtained during
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
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Class II · 6 months ago
Xiamen Kang Zhongyuan Biotechnology Co., Ltd. QC Quality Choice 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
Huons Co., Ltd. Lidocaine HCl Injection, USP, 2%, 100 mg/5mL , 5 mL Single-Dose Vials recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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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
Island Kinetics, Inc. d.b.a. CoValence Laboratories Blemish Spot Treatment 1% recall: Failed Stability Specifications
Failed Stability Specifications
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Class II · 6 months ago
Owen Biosciences Inc. HydroPeptide Clear Alliance Serum, 2.5% Benzoyl Peroxide 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. QC Quality Choice 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
Huons Co., Ltd. Lidocaine HCl injection, USP, 1% 50mg/5mL , 5 mL Single Dose Vials recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class III · 6 months ago
Avantor Performance Materials LLC Magnesium Chloride, 6-Hydrate, Crystal recall: Subpotent drug
Subpotent drug
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Class II · 6 months ago
Huons Co., Ltd. Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 6 months ago
Cipla USA, Inc. Cinacalcet Hydrochloride Tablets, 60 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