Drugs & supplements recalls
Prescription medicines, over-the-counter products and compounded drugs withdrawn from distribution.
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Class II · last month
Accord Healthcare, Inc. Levothyroxine Sodium Tablets, USP, 137 mcg recall: Subpotent Drug
Subpotent Drug
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Class II · last month
Accord Healthcare, Inc. Levothyroxine Sodium Tablets, USP, 25 mcg , 1000-count bottles recall: Subpotent Drug
Subpotent Drug
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Class II · last month
Accord Healthcare, Inc. Levothyroxine Sodium Tablets, USP, 125 mcg recall: Subpotent Drug
Subpotent Drug
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Class II · last month
Accord Healthcare, Inc. Levothyroxine Sodium Tablets, USP, 50 mcg , 1000-count bottles recall: Subpotent Drug
Subpotent Drug
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Class II · last month
Hikma Pharmaceuticals USA INC. Ramipril Capsules USP, 10 mg recall: Failed Impurities/Degradation Specifications: OOS result obtained
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
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Class II · last month
Accord Healthcare, Inc. Levothyroxine Sodium Tablets, USP, 200 mcg recall: Subpotent Drug
Subpotent Drug
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Class II · 2 months ago
American Regent, Inc. Tralement , packaged in a) 1mL Single Dose vials and b) 5x1mL recall: Presence of Particulate Matter: Product contaminated with particulate matter
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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Class II · 2 months ago
American Regent, Inc. Cyanocobalamin injection USP, 1,000 mcg/mL recall: Presence of Particulate Matter: Product contaminated with particulate matter
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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Class II · 2 months ago
Sun Pharmaceutical Industries Inc Carbamazepine Tablets, USP, 200mg recall: CGMP Deviations; black spots found on tablets from burnt excipient during
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
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Class I · 2 months ago
Fresenius Kabi USA, LLC Morphine Sulfate Injection, USP, 2 mg /mL recall: Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
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Class II · 2 months ago
American Regent, Inc. Selenious Acid Injection, USP 12 mcg/2 mL recall: Presence of Particulate Matter: Product contaminated with particulate matter
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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Class II · 2 months ago
American Regent, Inc. Aminaocaproic Acid Injection, USP, 250 mg/mL recall: Presence of Particulate Matter: Product contaminated with particulate matter
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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Class II · 2 months ago
American Regent, Inc. niCARdipine Hydrochloride Injection, USP, 25 mg/10mL recall: Presence of Particulate Matter: Product contaminated with particulate matter
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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Class II · 2 months ago
Shilpa Medicare Limited Pemrydi RTU , 500 mg/50 mL , Single-dose vial recall: Discolored solution. The firm has received market complaints reporting green
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
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Class II · 2 months ago
Mylan Pharmaceuticals Inc Acamprosate Calcium, Delayed-Release Tablets, 333 mg recall: Failed Dissolution Specifications
Failed Dissolution Specifications
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Class II · 2 months ago
American Regent, Inc. Nitroglycerin injection, USP, 50 mg/10 mL recall: Presence of Particulate Matter: Product contaminated with particulate matter
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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Class II · 2 months ago
Regeneron Pharmaceuticals Inc Libtayo Injection, 350 mg/7 mL recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 2 months ago
American Regent, Inc. Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use recall: Presence of Particulate Matter: Product contaminated with particulate matter
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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Class II · 2 months ago
Shilpa Medicare Limited Pemrydi RTU , 100 mg/10 mL , Single-dose vial recall: Discolored solution. The firm has received market complaints reporting green
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
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Class II · 2 months ago
American Regent, Inc. Acetylcysteine Solution, USP, 10% , packaged in a) 4 mL Vial recall: Presence of Particulate Matter: Product contaminated with particulate matter
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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Class I · 2 months ago
American Regent, Inc. Papaverine HCl Injection, USP, 60 mg/2 mL recall: Presence of Particulate Matter: Product contaminated with particulate matter
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
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Class II · 2 months ago
American Regent, Inc. Acetylcysteine Solution, USP, 20% , packaged in a) 4 mL Vial recall: Presence of Particulate Matter: Product contaminated with particulate matter
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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Class II · 2 months ago
American Regent, Inc. Multrys , For intravenous infusion recall: Presence of Particulate Matter: Product contaminated with particulate matter
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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Class II · 2 months ago
Golden State Medical Supply Inc. Carbamazepine Tablets, USP, 200mg recall: CGMP deviations: tablets with black specks
CGMP deviations: tablets with black specks.