Medicines, 2016
Shortlist up to four to read them side by side.
1,254 medicine recalls FDA’s Enforcement Report published in 2016, 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.
1,254of 1,254 medicine recallsshown with your filters
The list
- Medicine recall NIACINAMIDE 100 MG/ML (PF), In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PROCAINE 2% (PF), In a) 2ML Vials and b) 10ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PROLINE 100MG/ML (PF), 5ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PYRIDOXAL 50 MG/THIAMINE 50 MG/LIDOCAINE 1% NS (PF), 2ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PYRIDOXINE HCL 100MG/ML (PF), In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PYRIDOXINE HCL 100MG/ML W/PRES (BENZYL ETOH 0.02%), 5ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall RIBOFLAVIN 10MG/ML (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SELENIUM 200MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TAURINE 50 MG/ML (PF), In a) 1ML Vials, b) 10ML Vials, and c) 20ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TAURINE 50 MG/ML W/PRES. (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TESTOSTERONE CYP 100 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, and d) 5 ML… Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TESTOSTERONE CYP 200 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML, and… Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TESTOSTERONE CYP 20 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials and b) 3ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TESTOSTERONE CYP 25 MG/ML W/PRES (BENZYL ETOH 2%), 5ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TESTOSTERONE CYP 50 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML Vials,… Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall THIAMINE 100 MG/ML, 2ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall THIAMINE 100 MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TMG 100 MG/ML (PF), 10ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TRYPTOPHAN 10MG/ML (PF), In a) 10ML Vials and b) 50ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ZINC CHLORIDE 10MG/ML IN NACL 0.29% (PF), 2ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ZINC SO4 10MG/ML (PF), Vials 2ML, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ARGININE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ZINC SO4 1MG/ML (PF), 2ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HCL 2MG/ML (PF), 5ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label is 02/2019, correct expiration date should be 02/2018 Class IIIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine 40 mcg/mL injection Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Bupivacaine 1mg/mL injection Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Fentanyl Citrate 50 mcg/ml injection, 2mL fill in a 3 mL syringe Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Succinylcholine Chloride 20 mg/mL injection , 5 mL syringe Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Ceftriaxone 1GM injection in Sterile Water, 10 mL BD syringe Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Hydromorphone HCl 1mg/ml injection Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Fentanyl Citrate injection, 50 mcg/mL, 50 mL lntravia IV Bag Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Propofol1% 10mg/mL injection, 20 mL BD syringe Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Epinephrine 100mcg/mL injection Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Epinephrine (PF) 10mcg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Midazolam (PF) 5mg/ml 25 mL BD syringe Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Adenosine 1mg/ml (PF) Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Fentanyl Citrate 2mcg/mL & Bupivacaine 0.125% Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Potassium Chloride 40 mEq Added to 0.9% Sodium Chloride 250 mL bag Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Norepinephrine 16 mg added to 0.9% sodium Chloride, 250 mL bag Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Promethazine 6.25 mg added to 0.9% Sodium Chloride 50 mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Methohexital (Brevital Sodium) 10 mg/mL,10 mL syringe Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Promethazine 25 mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx, Only, Compounded… Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Phenylephrine HCI 40mg/250 mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall HYDROmorphone 1mg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
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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