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Independent register of U.S. FDA drug recalls · updated Oct 10, 2026

FDA drug recalls in 2016

Every FDA drug recall initiated in 2016, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.

1,199 recalls, newest first.

Apr 20, 2016 Class II · Moderate risk

Potassium Chloride 40 mEq Added to 0.9% Sodium Chloride 250 mL bag

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0173-02 D-1271-2016

Apr 20, 2016 Class II · Moderate risk

Fentanyl Citrate 2mcg/mL & Bupivacaine 0.125% in 0.9% Sodium Chloride 150 mL Intravia bag

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0171-01 D-1270-2016

Apr 20, 2016 Class II · Moderate risk

Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium…

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0148-48 D-1269-2016

Apr 20, 2016 Class II · Moderate risk

Adenosine 1mg/ml

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0146-47 D-1268-2016

Apr 20, 2016 Class II · Moderate risk

Midazolam

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0138-67 D-1267-2016

Apr 20, 2016 Class II · Moderate risk

Epinephrine

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0135-70 D-1266-2016

Apr 20, 2016 Class II · Moderate risk

Epinephrine 100mcg/mL injection in 0.9% Sodium Chloride 10 mL BD syringe

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0120-72 D-1265-2016

Apr 20, 2016 Class II · Moderate risk

Propofol1% 10mg/mL injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0119-73 D-1264-2016

Apr 20, 2016 Class II · Moderate risk

Fentanyl Citrate injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0118-41 D-1263-2016

Apr 20, 2016 Class II · Moderate risk

Hydromorphone HCl 1mg/ml injection in 0.9% Sodium Chloride

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0114-48 D-1262-2016

Apr 20, 2016 Class II · Moderate risk

Ceftriaxone 1GM injection in Sterile Water

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0106-72 D-1261-2016

Apr 20, 2016 Class II · Moderate risk

Succinylcholine Chloride 20 mg/mL injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0104-70 D-1260-2016

Apr 20, 2016 Class II · Moderate risk

Fentanyl Citrate 50 mcg/ml injection

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0100-69 D-1259-2016

Apr 20, 2016 Class II · Moderate risk

Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection in 0.9% Sodium Chloride

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0029-01 D-1258-2016

Apr 20, 2016 Class II · Moderate risk

Bupivacaine 1mg/mL injection in 0.9% Sodium Chloride 250 mL bag

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0019-02 D-1257-2016

Apr 20, 2016 Class II · Moderate risk

Phenylephrine 40 mcg/mL injection in 0.9% Sodium Chloride 10 mL syringe

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0011-72 D-1256-2016

Apr 18, 2016 Class II · Moderate risk

Vancomycin 2 grams in 540 mL 0.9% NS bags

Lack of Sterility Assurance.

Terminated Sterility / contamination Baptist Health Medical Towers Pharmacy and Infusion Services D-0948-2016

Apr 18, 2016 Class II · Moderate risk

Vancomycin 1 grams in 250 mL 0.9% NS bags

Lack of Sterility Assurance

Terminated Sterility / contamination Baptist Health Medical Towers Pharmacy and Infusion Services D-0947-2016

Apr 18, 2016 Class II · Moderate risk

Vancomycin 1750 mg in 270 mL 0.9% NS bag

Lack of Sterility Assurance

Terminated Sterility / contamination Baptist Health Medical Towers Pharmacy and Infusion Services D-0946-2016

Apr 18, 2016 Class II · Moderate risk

Vancomycin 1500 mg in 270 mL 0.9% NS bag

Lack of Sterility Assurance.

Terminated Sterility / contamination Baptist Health Medical Towers Pharmacy and Infusion Services D-0945-2016

Apr 18, 2016 Class II · Moderate risk

Vancomycin 1250 mg in 250 mL 0.9% NS bags

Lack of Sterility Assurance.

Terminated Sterility / contamination Baptist Health Medical Towers Pharmacy and Infusion Services D-0944-2016

Apr 18, 2016 Class II · Moderate risk

Vancomycin 1000 mg in 250 mL 0.9% NS bag

Lack of Sterility Assurance

Terminated Sterility / contamination Baptist Health Medical Towers Pharmacy and Infusion Services D-0943-2016

Apr 18, 2016 Class II · Moderate risk

Vancomycin 750 mg in 250 mL 0.9% NS bag

Lack of Sterility Assurance.

Terminated Sterility / contamination Baptist Health Medical Towers Pharmacy and Infusion Services D-0942-2016

Apr 18, 2016 Class II · Moderate risk

Vancomycin 500 mg in 250 mL 0.9% NS bag

Lack of Sterility Assurance

Terminated Sterility / contamination Baptist Health Medical Towers Pharmacy and Infusion Services D-0941-2016

Apr 18, 2016 Class II · Moderate risk

Water for Injection 1000 mL Bags

Lack of Sterility Assurance

Terminated Sterility / contamination Baptist Health Medical Towers Pharmacy and Infusion Services D-0940-2016

Recalls by year

2026563
2025778
2024557
20231,122
20221,390
20211,152
2020930
20191,788
20181,681
20171,141
20161,199
20151,733
20141,309
20132,085
2012534
201134
20104
20072
20061