Browse Drug Recalls
989 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 989 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 989 FDA drug recalls in TN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 2, 2015 | Tri-Mix (30/1/20) Injectable, 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 | Testosterone 50 mg Pellet, Sterile, The Compounding Pharmacy of America, Inc.... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | The Compounding Pharmacy of America |
| Jun 2, 2015 | PGE 150 (Alprostadil) 150 mcg/ml, ml, Multi-Dose Vial, Sterile, Keep Frozen, ... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | The Compounding Pharmacy of America |
| Jun 2, 2015 | Testosterone USP Aqueous 200 mg/ml Injection, 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 | Morphine 40 mg/ml + Bupivacaine 8 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 | Hydromorphone 12.5 mg/ml Solution, Sterile-Preservative Free, 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 | MIC-B COMPLEX Injectable, Multi-Dose Vial, Sterile, Room Temperature, 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 35 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 (20/1/10) Injectable, Sterile, Keep Frozen, 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 | Methylcobalamin 5,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigera... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | The Compounding Pharmacy of America |
| Jun 2, 2015 | Testosterone Cypionate 200 mg/ml Anastrazole 0.5 mg/ml Injection, Multi-Do... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | The Compounding Pharmacy of America |
| Jun 2, 2015 | Morphine 60 mg/ml + Fentanyl 12,000 mcg/ml + Bupivacaine 40 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 | HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 23 DAY KIT, 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 1,100 IU/ml + Methylcobalamin 0.5 mg/ml Injection, ml Multi-Dose Vial, St... | 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 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 Cypionate 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Te... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | The Compounding Pharmacy of America |
| Jun 2, 2015 | Testosterone 30 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 | 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 |
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.