Medicines, 2015
Shortlist up to four to read them side by side.
2,020 medicine recalls FDA’s Enforcement Report published in 2015, newest first; 18,075 in all since 2012.
FDA’s medicine recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 5, 2026.
2,020of 2,020 medicine recallsshown with your filters
The list
- Medicine recall Cyanocobalamin 1,000 mcg/ml + B-Complex 100 mg/ml, ml, Multi-Dose Vial, Sterile, Room Temperature, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cyanocobalamin 1,000 mcg/ml + B-Complex 500 mg/ml, ml, Multi-Dose Vial, Sterile, Room Temperature, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dexpanthenol 215 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dexpanthenol 250 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DMPS (Sodium 2, 3 Dimercaptopropane Sulfonate) 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol 10 mg Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol 15 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol 18 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol 22 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol 3 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol 4 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol 50 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol 6 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol 8 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol Cypionate 5mg/ml Injectable, ml Multi-Dose Vial, Sterile Room Temperature, The Compounding Pharmacy… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol Valerate 20 mg/ml Injectable ml Multi-Dose Vial, Sterile, Room Temperature, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol Valerate 40 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl 10,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile-Preservative Free, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl 100 mcg/ml +Clonidine 400 mcg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Clonidine 1,300 mcg/ml + Baclofen 300 mcg/ml Intrathecal… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl 20,000 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,300 mcg/ml + Baclofen 350 mcg/ml Intrathecal… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl 3,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative Free, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl 4,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl 7,000 mcg/ml + Bupivacaine 6 mg/ml + Clonidine 40 mcg/ml Intrathecal Solution, Sterile-Preservative… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl 8,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl 950 mcg/ml + Bupivacaine 5 mg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl 1,000 mcg/ml + Bupivacaine 25 mg/ml Baclofen 500 mcg/ml + Clonidine 500 mcg/ml Intrathecal Solution,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl 17,500 mcg/ml + Clonidine 1,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl 2,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative Free, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl 2,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, Sterile - Preservative Free, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl 2,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl 5,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl 5,000 mcg/ml + Baclofen 250 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl 5,000 mcg/ml, + Bupivacaine 15 mg/ml Intrathecal Solution, Sterile - Preservative Free, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl 5,000 mcg/ml + Clonidine 3,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl 500 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl 7,500 mcg/ml, + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative Free, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl 8,000 mcg/ml, + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile - Preservative Free, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Folic Acid 5 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glutathione 200 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America,… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HCG 1,000 IU/ml + Hydroxocobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HCG 1,000 IU/ml + Methylcobalamin 0.05 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HCG 1,000 IU/ml + Methylcobalamin 0.5 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding… Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Drug recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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