Recalls published in November 2025
Everything the FDA, USDA FSIS, CPSC and NHTSA announced in November 2025, newest first.
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Class II · 12 months ago
Farmakeio Outsourcing LLC Testosterone / Triamcinolone Acetonide Pellet recall: CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
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Class II · 12 months ago
Amerisource Health Services LLC Prazosin Hydrochloride, Capsules, USP, 2 mg recall: Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA)…
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Class II · 12 months ago
Farmakeio Outsourcing LLC Testosterone 25MG, 1 Pellet FOR Subcutaneous Insertion recall: CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
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Class II · 12 months ago
Otsuka ICU Medical LLC 0.9% Sodium Chloride Injection, USP, 100 mL recall: Lack of Assurance of Sterility: Potential for flexible container leaks
Lack of Assurance of Sterility: Potential for flexible container leaks.
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Class II · 12 months ago
ProRx LLC Semaglutide Injection, 5 mg/2 mL , 2mL Multidose Vial recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 12 months ago
Farmakeio Outsourcing LLC Testosterone / Triamcinolone Acetonide Pellet recall: CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
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Class III · 12 months ago
Endo USA, Inc. Everolimus tablets 2.5 mg, 28 tablets recall: Failed Impurities/Degradation Specifications: Out of specification
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
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Class II · 12 months ago
Farmakeio Outsourcing LLC Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG recall: CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
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Class II · 12 months ago
ProRx LLC Semaglutide Injection, 12.5/5mL , 5mL Multidose Vial recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 12 months ago
Amerisource Health Services LLC Prazosin Hydrochloride, Capsules, USP, 5 mg recall: Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA)…
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Class II · 12 months ago
Sun Pharmaceutical Industries Inc Lisdexamfetamine Dimesylate Capsules, 50 mg recall: Failed Dissolution Specifications: An out of specification results observed
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability…
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Class II · 12 months ago
Kenvue Brands LLC Tylenol, Acetaminophen, Extra Strength, 24 Caplets recall: Defective Container
Defective Container
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Class II · 12 months ago
Heritage Pharmaceuticals Inc Desipramine Hydrochloride Tablets, USP, 150 mg recall: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
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Class II · 12 months ago
Farmakeio Outsourcing LLC Testosterone / Triamcinolone Acetonide Pellet recall: CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
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Class II · 12 months ago
ProRx LLC Tirzepatide Injection, 27 mg/3 mL , 3mL Multidose Vial recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class II · 12 months ago
Samsung Bioepis Co., Ltd. Hadlima injection, 40mg/0.8 mL recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility.
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Class II · 12 months ago
ProRx LLC Semaglutide Injection, 8mg/3.2mL , 3.2mL Multidose Vial recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
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Class III · 12 months ago
Endo USA, Inc. Everolimus tablets 7.5mg, 28 tablets recall: Failed Impurities/Degradation Specifications: Out of specification
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
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Class III · 12 months ago
Letco Medical LLC Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604 recall: Labeling: Not Elsewhere Classified
Labeling: Not Elsewhere Classified
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Class II · 12 months ago
Farmakeio Outsourcing LLC Testosterone 62.5 MG, 1 Pellet FOR Subcutaneous Insertion recall: CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
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Class II · 12 months ago
Heritage Pharmaceuticals Inc Desipramine Hydrochloride Tablets, USP, 25 mg recall: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
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Class II · 12 months ago
Farmakeio Outsourcing LLC Testosterone 50MG, 1 Pellet FOR Subcutaneous Insertion recall: CGMP Deviations: Potential presence of metal particulate matter
CGMP Deviations: Potential presence of metal particulate matter
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Class II · 12 months ago
Teva Pharmaceuticals USA, Inc Prazosin Hydrochloride, Capsules, USP, 1 mg recall: CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable…
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Class II · 12 months ago
Sun Pharmaceutical Industries Inc Lisdexamfetamine Dimesylate Capsules, 60 mg recall: Failed Dissolution Specifications: An out of specification results observed
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability…