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 Hydromorphone 70 mg/ml Solution, Sterile-Preservative Free, 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 Hydroxocobalamin 1,000 mcg/ml Injection, 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 Hydroxocobalamin 10,000 mcg/ml Injection, 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 Hydroxocobalamin 5,000 mcg/ml Injection, 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 Hydroxocobalamin 10 mg/ml Folic Acid 4 mg/ml Injectable, ml 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 Hydroxyprogesterone Caproate 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 L-Arginine 100 mg/ml Injectable, 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 Lidocaine 1% Injection, 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 Lidocaine 2% with Epinephrine 1:100,000 (Buffered) 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 Magnesium Chloride 200 mg/ml 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 Magnesium Sulfate 500 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 Mannitol 5% Injectable, Multi-Dose Vial, Sterile, Room Temperature, 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 Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 25 mg/ml Injectable, Multi-Dose Vial, Sterile, Room… 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 Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Room… 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 Methylcobalamin 1,000 mcg/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 Methylcobalamin 10,000 mcg/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 Methylcobalamin 4,000 mcg/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 Methylcobalamin 5,000 mcg/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 Methylcobalamin 25,000 mcg/ml Intramuscular, Multi-Dose Vial, Sterile, Refrigerate, 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 Methylcobalamin 10 mg/ml + 5 Methyl Tetrahydrofolate 4 mg/ml Injectable, Sterile-Multi-Dose Vial,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 Methylcobalamin 1,000 mcg/ml + Hydroxocobalamin 1,000 mcg/ml Injectable, Preservative Free, Sterile,… 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 Methylcobalamin 7.5 mg/ml + Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injection, Multi-Dose… 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 MIC+Methylcobalamin 4000 mcg/ml Injection, 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 MIC-B COMPLEX Injectable, Multi-Dose Vial, Sterile, Room Temperature, 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 MIC-B12+B6 Injection, Multi-Dose Vial, Sterile, Room Temperature, 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 MIC-PLUS Carnitine Injectable, Multi-Dose Vial, Sterile, Room Temperature, 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 Mitomycin 0.02% Ophthalmic Solution, single dose dropper, Keep Frozen, 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 Mitomycin 0.03% Ophthalmic Solution, ml single dose dropper, Keep Frozen, 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 Mitomycin 40 mg/40 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, 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
- Medicine recall Mitomycin 40 mg/50 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, 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 Morphine 10 mg/ml Solution, Sterile-Preservative Free, 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 Morphine 12.5 mg/ml Solution, Sterile-Preservative Free,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 Morphine 15 mg/ml Solution, Sterile-Preservative Free, 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 Morphine 20 mg/ml Solution, Sterile-Preservative Free, 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 Morphine 20 mg/ml + Clonidine 400 mcg/ml Solution Sterile-Preservative Free, 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 Morphine 20 mg/ml + Clonidine 500 mcg/ml Solution, Sterile-Preservative Free, 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 Morphine 25 mg/ml + Baclofen 100 mcg/ml Solution, Sterile-Preservative Free, 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 Morphine 25 mg/ml Solution, Sterile-Preservative Free, 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 Morphine 30 mg/ml + Baclofen 10 mcg/ml Solution, Sterile-Preservative Free, 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 Morphine 30 mg/ml + Bupivacaine 5 mg/ml Solution, Sterile-Preservative Free, 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 Morphine 30 mg/ml + Clonidine 250 mcg/ml Solution, Sterile-Preservative Free, 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 Morphine 33 mg/ml Solution, Sterile-Preservative Free, 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 Morphine 35 mg/ml Solution, Sterile-Preservative Free, 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 Morphine 36 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile- Preservative Free, 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 Morphine 40 mg/ml Solution, Sterile-Preservative Free, 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 Morphine 40 mg/ml + Bupivacaine 16 mg/ml Solution, Sterile-Preservative Free, 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 Morphine 40 mg/ml + Bupivacaine 8 mg/ml Solution, Sterile-Preservative Free, 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 Morphine 40 mg/ml + Clonidine 500 mcg/ml Solution, Sterile-Preservative Free, 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
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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