Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

5851–5875 of 8593

SevereFDA (Drugs)·D-1713-2015·2015-09-23
FDA Recalls Compounded Sterile Morphine and Fentanyl Solution for Sterility Concerns
The Compounding Pharmacy of America is recalling a sterile compounded solution containing morphine, fentanyl, bupivacaine, and clonidine due to FDA-identified GMP violations that may impact sterility.
Product
Morphine 60 mg/ml + Fentanyl 12,000 mcg/ml + Bupivacaine 40 mg/ml + Clonidine 1,400 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1597-2015·2015-09-23
Morphine Solution Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Morphine 35 mg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility.
Product
Morphine 35 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1578-2015·2015-09-23
Compounding Pharmacy Recalls MIC-B Complex Injectable Due to Sterility Concerns
The Compounding Pharmacy of America is recalling MIC-B Complex Injectable vials because FDA inspections found GMP violations that may affect sterility.
Product
MIC-B COMPLEX Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1648-2015·2015-09-23
Testosterone Injection Recalled for Potential Sterility Issues
The Compounding Pharmacy of America is recalling Testosterone USP Aqueous 200 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
Product
Testosterone USP Aqueous 200 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1703-2015·2015-09-23
FDA Recalls Morphine and Bupivacaine Compounded Solution Due to Sterility Concerns
The Compounding Pharmacy of America is recalling a sterile morphine and bupivacaine solution because FDA inspections found violations that may affect sterility.
Product
Morphine 45 mg/ml + Bupivacaine 8 mg/ml + Baclofen 25 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1470-2015·2015-09-23
Estradiol Pellets Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Estradiol 22 mg sterile pellets nationwide because FDA inspections found GMP violations that may affect sterility.
Product
Estradiol 22 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1605-2015·2015-09-23
Morphine Solution Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Morphine 45 mg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility.
Product
Morphine 45 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1632-2015·2015-09-23
Sermorelin Injection Recalled for Lack of Sterility Assurance
The Compounding Pharmacy of America is recalling Sermorelin injections due to FDA inspection findings of GMP violations that may impact sterility.
Product
Sermorelin 1000mcg/GHRP6 1000/GHRP2 1000 ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1680-2015·2015-09-23
FDA Recalls Intrathecal Solution Due to Sterility Concerns
The Compounding Pharmacy of America is recalling Hydromorphone, Bupivacaine, and Clonidine intrathecal solution because FDA inspections found GMP violations affecting sterility.
Product
Hydromorphone 70 mg/ml + Bupivacaine 20 mg/ml + Clonidine 125 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1532-2015·2015-09-23
HCG Injection Recalled for Lack of Sterility Assurance
The Compounding Pharmacy of America is recalling HCG 1,200 IU/ml Injection vials due to FDA inspection findings of GMP violations that impact sterility.
Product
HCG 1,200 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1574-2015·2015-09-23
FDA Recalls Methylcobalamin and Methyl Tetrahydrofolate Injectable Due to Sterility Concerns
The Compounding Pharmacy of America is recalling Methylcobalamin and Methyl Tetrahydrofolate injectable vials because an FDA inspection found GMP violations that may affect sterility.
Product
Methylcobalamin 10 mg/ml + 5 Methyl Tetrahydrofolate 4 mg/ml Injectable, Sterile-Multi-Dose Vial,Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1663-2015·2015-09-23
Zinc Chloride Injectable Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Zinc Chloride 25mg/ml Injectable due to FDA inspection findings of GMP violations that may impact sterility.
Product
Zinc Chloride 25mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1490-2015·2015-09-23
FDA Recalls Compounded Fentanyl and Bupivacaine Intrathecal Solution for Sterility Concerns
The Compounding Pharmacy of America is recalling specific lots of compounded intrathecal solution due to FDA inspection findings of GMP violations that may impact sterility.
Product
Fentanyl 1,000 mcg/ml + Bupivacaine 25 mg/ml Baclofen 500 mcg/ml + Clonidine 500 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1530-2015·2015-09-23
HCG Injection Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling HCG 4,000 IU/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
Product
HCG 4,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1475-2015·2015-09-23
Estradiol Pellets Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Estradiol 6 mg sterile pellets nationwide because FDA inspections found GMP violations that may impact sterility.
Product
Estradiol 6 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1450-2015·2015-09-23
Cholecalciferol Injectable Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Cholecalciferol 50,000 IU/ml Injectable vials because FDA inspections identified GMP violations that may impact sterility.
Product
Cholecalciferol 50,000 IU/ml Injectable, Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1755-2015·2015-09-23
Testosterone Cypionate Injection Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Testosterone Cypionate 250 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
Product
Testosterone Cypionate 250 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1779-2015·2015-09-23
Tri-Mix Injectable Recalled for Potential Sterility Issues
The Compounding Pharmacy of America is recalling Tri-Mix Injectable due to FDA inspection findings of GMP violations that may impact sterility.
Product
Tri-Mix (30/1/20) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1796-2015·2015-09-23
Tri-Mix ST4 Injectable Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Tri-Mix ST4 Injectable due to GMP violations that may impact sterility. The recall covers lots distributed nationwide from November 2014 to May 2015.
Product
Tri-Mix ST4 (3 mg/1.5 mg/300 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1614-2015·2015-09-23
FDA Recalls Morphine and Bupivacaine Solution Due to Sterility Concerns
The Compounding Pharmacy of America is recalling Morphine and Bupivacaine solution nationwide due to FDA inspection findings regarding sterility assurance.
Product
Morphine 70 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1762-2015·2015-09-23
Tri-Mix Injectable Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Tri-Mix injectable products because an FDA inspection found GMP violations that may affect sterility.
Product
Tri-Mix (15 mg/0.5 mg/5 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1609-2015·2015-09-23
Morphine and Clonidine Solution Recalled for Sterility Concerns
The Compounding Pharmacy of America is recalling Morphine and Clonidine solution due to FDA inspection findings regarding sterility assurance.
Product
Morphine 50 mg/ml + Clonidine 100 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1460-2015·2015-09-23
Cyanocobalamin and B-Complex Injection Recalled for Sterility Concerns
The Compounding Pharmacy of America is recalling Cyanocobalamin and B-Complex injections due to FDA inspection findings of GMP violations that may impact sterility.
Product
Cyanocobalamin 1,000 mcg/ml + B-Complex 500 mg/ml, ml, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1505-2015·2015-09-23
FDA Recalls HCG and Methylcobalamin Injection Due to Sterility Concerns
The Compounding Pharmacy of America is recalling HCG and Methylcobalamin injections nationwide because FDA inspections found violations that may have compromised product sterility.
Product
HCG 1,000 IU/ml + Methylcobalamin 0.05 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1514-2015·2015-09-23
Compounded HCG Injection Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling HCG 625 IU/ml Injection kits due to FDA inspection findings regarding GMP violations and lack of sterility assurance.
Product
HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 40 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide

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5851–5875 of 8593