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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 Morphine 50 mg/ml + Fentanyl 20,000 mcg/ml + Bupivacaine 30 mg/ml + Clonidine... 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-102 (17.65 mg/0.59 mg/10 mcg) Injectable, The Compounding Pharmacy ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 LIPO-DEN MODIFIED Injection, 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 Morphine 70 mg/ml + Clonidine 1,100 mcg/ml Solution, Sterile-Preservative Fre... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Estradiol 3 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Kn... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Estradiol 10 mg Sterile Pellet, 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 Morphine 50 mg/ml + Bupivacaine 2.5 mg/ml Solution, Sterile-Preservative Free... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 LIPOLEAN + Ascorbic Acid 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Room ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Nandrolone Decanoate 250 mg/ml Injection, ml Multi-Dose Vial, Sterile, Room T... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Hydroxyprogesterone Caproate (17-HP) 250 mg/ml Injectable, Multi-Dose Vial, R... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 HCG 2,500 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 Alprostadil 20 mcg/ml Injection, Sterile, Keep Frozen, 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 Hydromorphone 70 mg/ml+Fentanyl 16,000 mcg/ml+Bupivacaine 15 mg/ml+Clonidine ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 MEGA-BURN, Winning at Weight Loss Formula Injectable, 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 Fentanyl 5,000 mcg/ml + Bupivacaine 40 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 Hydromorphone 40 mg/ml + Bupivacaine 20 mg/ml Solution, Sterile-Preservative ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Testosterone 18 mg, Sterile Pellet, 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 Clotrimazole 2% Otic Suspension, ml, Sterile, Room Temperature, Shake Well, T... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Lipotropic B-12 Injection, Multi-Dose Vial, Sterile, Room Temperature, The Co... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Ascorbic Acid 1.25% Glutathione 1.25% DMSO 6.25% Ophthalmic Solution, Steri... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Estradiol 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxvil... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Fentanyl 3,000 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 45 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile-Preservative Free,... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 PGE 80 (Alprostadil) 80 mcg/ml Injection, 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 Hydromorphone 1 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Co... 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 ST2/LIDO2/PGE2 0.2/0.1/0.04, Injectable, The Compounding Pharmacy of ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Glutathione 200 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The C... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Fentanyl 8,000 mcg/ml, + Bupivacaine 40 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 Fentanyl 2,000 mcg/ml + Bupivacaine 30 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 Testosterone 25 mg, Sterile Pellet, 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 Mitomycin 40 mg/40 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, Re... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Biotin10 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, 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 Hydromorphone 60 mg/ml + Bupivacaine 30 mg/ml Solution, Sterile-Preservative ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Morphine 40 mg/ml + Bupivacaine 16 mg/ml Solution, Sterile-Preservative Free,... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Morphine 25 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 Tri-Mix ST4/PGE 2/LIDO 2 0.1/0.05/0.05 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 Hydroxocobalamin 10 mg/ml Folic Acid 4 mg/ml Injectable, ml Multi-Dose Vial, ... 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 (17.7/0.59/6) (MFG) Injectable, Sterile, Keep Frozen, The Compounding... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 LIPO-Tropic Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compo... 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 + Bupivacaine 15 mg/ml Solution, St... 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 + Bupivacaine 5 mg/ml Solution, Sterile-Preservative Free, ... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Buckshot Injectable, Multi-Dose, Sterile, Room Temperature, 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 Fentanyl 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free,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 Morphine 30 mg/ml + Clonidine 250 mcg/ml Solution, Sterile-Preservative Free,... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Sermorelin/GHRP2 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 Oxytocin 100 units/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The C... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Nandrolone Decanoate 200 mg/ml Injection, ml Multi-Dose Vial, Sterile, Room T... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 LIPO-EXTREME Injectable, 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 Sermorelin 300 mcg/ml + GHRP-2 300 mcg/ml Injection, Multi-Dose Vial, Sterile... Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... Class II The Compounding Pharmacy of America
Jun 2, 2015 Folic Acid 5 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Comp... 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.