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The Compounding Pharmacy of America

Complete recall history across all FDA and CPSC categories — 383 total recalls

The Compounding Pharmacy of America appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (383)

FDA drug safety enforcement actions by The Compounding Pharmacy of America. Showing most recent 50.

Date Product Reason Class
Jan 12, 2018 HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial,... Non-Sterility Class I
Jun 2, 2015 Estradiol 4 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Kn... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Testosterone 62.5 mg Pellet, Sterile, The Compounding Pharmacy of America, Kn... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Alprostadil 40 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharma... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Hydroxocobalamin 5,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerat... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 DMPS (Sodium 2, 3 Dimercaptopropane Sulfonate) 50 mg/ml Injectable, Multi-Dos... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Testosterone 60 mg, Sterile Pellet, The Compounding Pharmacy of America, Knox... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 MEGA-BURN III Injection, Multi-Dose Vial, Sterile, Room Temperature, The Comp... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Estradiol 18 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxvil... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 MEGA-BURN Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compound... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 PGE 40 (Alprostadil) 40 mcg/ml Injection, ml, Multi-Dose Vial, Sterile, Keep ... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Hydromorphone 60 mg/ml + Fentanyl 1,000 mcg/ml + Bupivacaine 10 mg/ml Intrath... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Hydromorphone 35 mg/ml + Bupivacaine 4 mg/ml Intrathecal Solution, Sterile-Pr... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Tri-Mix T-50/PGE 2/LIDO 2 0.03/0.18/0.09 Injectable, The Compounding Pharmacy... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Vancomycin 25 mg/ml Ophthalmic Solution, Single Dose, Sterile, Keep Frozen, T... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 MIC-PLUS Carnitine Injectable, Multi-Dose Vial, Sterile, Room Temperature, Th... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Morphine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharma... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Fentanyl 4,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile-Pr... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Tri-Mix (20/2.5/20) Injectable, Sterile, Keep Frozen, The Compounding Pharma... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 HCG 1,500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compound... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Morphine 64 mg/ml + Bupivacaine 10 mg/ml Solution, Sterile-Preservative Free,... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Lipotropic B-12 II* + Lidocaine Injection, Multi-Dose Vial, Sterile, Room Tem... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 HCG 1,000 IU/ml + MIC B-12 Injection, Multi-Dose Vial, Sterile, Refrigerate, ... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Tri-Mix ST2 (30 mg/3 mg/100 mcg) Injectable, The Compounding Pharmacy of Amer... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Bupivacaine 15 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Com... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Testosterone Cypionate 50 mg/ml Injection, Multi-Dose Vial, Sterile, Room Tem... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Tri-Mix (17.7 mg/1 mg/10 mcg) Injectable, Sterile, Keep Frozen, The Compoundi... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Testosterone Cypionate 40 mg/ml Injectable, 5 Sesame, The Compounding Pharmac... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Tri-Mix T-50/PGE 2/LIDO 2 0.09/0.32/0.04 Injectable, The Compounding Pharmacy... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Morphine 50 mg/ml + Clonidine 750 mcg/ml + Baclofen 15 mcg/ml Solution, Steri... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Testosterone 70 mg Pellet, Sterile, The Compounding Pharmacy of America, Knox... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Progesterone 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature,... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Tri-Mix (17 mg/0.5 mg/6 mcg) Injectable, Sterile, Keep Frozen, The Compoundin... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Tri-Mix ST9C (30 mg/2 mg/120 mcg) Injectable, The Compounding Pharmacy of Ame... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Morphine 50 mg/ml + Fentanyl 10,000 mcg/ml + Bupivacaine 25 mg/ml, Solution, ... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Bupivacaine 40 mg/ml +Baclofen 130 mcg/ml Intrathecal Solution, Sterile-Prese... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Estradiol Valerate 20 mg/ml Injectable ml Multi-Dose Vial, Sterile, Room Temp... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Hydromorphone 65 mg/ml Solution, Sterile-Preservative Free, The Compounding P... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Methylcobalamin 4,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerat... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 MEGA-BURN* Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compou... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Testosterone 200 mg, Sterile Pellet, The Compounding Pharmacy of America, Kno... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Testosterone USP (10 AQUEOUS) 100 mg/ml Injection, Multi-Dose Vial, Sterile, ... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Estradiol 15 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxvil... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Bi-Mix #1 (17.365 mg/0.59 mg) Injectable, Sterile, Keep Frozen, The Compoundi... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Testosterone Cypionate 220 mg/ml Injection, Multi-Dose Vial, Sterile, Room Te... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Tri-Mix (10/0.174/16) Injectable, Sterile, Keep Frozen, The Compounding Pharm... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
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 pote... Class II
Jun 2, 2015 Methylcobalamin 10,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigera... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Mannitol 5% Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compo... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II
Jun 2, 2015 Hydromorphone 70 mg/ml Solution, Sterile-Preservative Free, The Compounding P... Lack of Assurance of Sterility; FDA inspection identified GMP violations pote... Class II

View all 383 drug recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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