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Browse Drug Recalls

383 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 383 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 383 FDA drug recalls.

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DateProductReasonClassFirm
Jun 2, 2015 Sermorelin/GHRP6 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrig... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Tri-Mix (25/2.5/10) Injectable, Sterile, Keep Frozen, The Compounding Pharmac... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Fentanyl 7,500 mcg/ml, + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile -... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Morphine 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharma... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Testosterone Bi-Blend 50 mg/ml + Estradiol Valerate 2.5 mg/ml Injectable, Th... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Testosterone 75 mg Pellet, Sterile, The Compounding Pharmacy of America, Knox... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Tri-Mix (25/2.5/10) (MFG) Injectable, Sterile, Keep Frozen, The Compounding P... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 HCG 10,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compoun... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Hyaluronidase 150 units/ml Injection, ml, Sterile, Preservative Free, Refrige... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 HCG 5,000 IU/ml + Methylcobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, S... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Tri-Mix (18 mg/0.6 mg/5.88 mcg) Injectable, Sterile, Keep Frozen, The Compou... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Tri-Mix T-105 (30 mg/1 mg/10 mcg) Injectable, The Compounding Pharmacy of Ame... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Intrat... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Acetyl-L-Carnitine 500 mg/ml, Injectable, Sterile-Multi-Dose Vial, The Compou... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Testosterone 80 mg Pellet, Sterile, The Compounding Pharmacy of America, Knox... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 MYO-DEN (30 ml) 25 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperatur... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Tri-Mix (15 mg/0.5 mg/20 mcg) Injectable, Multi-Dose Vial, Sterile, Keep Froz... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Cholecalciferol 600,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compoundin... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Zinc 5 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compoundi... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Hyaluronidase 150 units/ml Injection, ml, Sterile, Preserved, Refrigerate, Th... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Methylcobalamin 1,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerat... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Neomycin + Polymyxin B+ Bacitracin Ophthalmic Ointment, grams, Refrigerate, T... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 HCG 2,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compound... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 5-Methy Tetrahydrofolate 5 mg/ml Injectable, Sterile-Multi-Dose Vial, The Com... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Fentanyl 950 mcg/ml + Bupivacaine 5 mg/ml Intrathecal Solution, Sterile-Prese... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Fentanyl 5,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Testosterone 37.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Kn... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Tri-Mix (30/1/22) (MFG) Injectable, The Compounding Pharmacy of America, Knox... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Lidocaine 1% Injection, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 B-Complex Injection, Sterile, Refrigerate, The Compounding Pharmacy of Americ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Tri-Mix (37.5/2/20) Injectable, The Compounding Pharmacy of America, Knoxvill... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Cyanocobalamin 1,000 mcg/ml, Multi-Dose vial, Sterile, Room Temperature, The... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 TRI-MIX (1/1/40) (MFG) Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Hydromorphone 10 mg/ml + Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 LIPO-VITE III, Injection Multi-Dose Vial, Sterile, Room Temperature, The Comp... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Hydroxocobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerat... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Magnesium Sulfate 500 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 MIC+Methylcobalamin 4000 mcg/ml Injection, Multi-Dose Vial, Sterile, Room Tem... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Tri-Mix (30/0.5/10) Injectable, Sterile, Keep Frozen, The Compounding Pharmac... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Lipotropic (w/Cyanocobalamin 4000 mcg/ml) Injection, Multi-Dose Vial, Steril... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Sufentanil 50 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pha... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Tri-Mix T-50 8.8 mg/0.29 mg/2.9 mcg Injectable, The Compounding Pharmacy of A... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Tri-Mix ST3/PGE 2/LIDO 2 0.06/0.2/0.02 Injectable, The Compounding Pharmacy o... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Morphine 50 mg/ml + Fentanyl 3,000 mcg/ml + Baclofen 450 mcg/ml, Sterile, Pre... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Morphine 50 mg/ml + Fentanyl 1,500 mcg/ml + Baclofen 800 mcg/ml +Clonidine 20... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injectable, Multi-... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Tri-Mix T-106/PGE 2 0.1/0.14 Injectable, The Compounding Pharmacy of America,... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Fentanyl 17,500 mcg/ml + Clonidine 1,000 mcg/ml Intrathecal Solution, Sterile... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Tri-Mix (37.5 mg/1.5 mg/50 mcg) Injectable, The Compounding Pharmacy of Amer... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.