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

966 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2016 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE

Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.

Terminated Sterility / contamination W & C dba The Apothecary D-1509-2016
Class II · Moderate risk

Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG

Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.

Terminated Sterility / contamination W & C dba The Apothecary D-1508-2016
Class II · Moderate risk

Oxacillin for Injection

Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.

Terminated Particulate / foreign matter Sagent Pharmaceuticals Inc NDC 25021-163-69 D-1450-2016
Class II · Moderate risk

Quad-Mix #3

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-1025-2016
Class II · Moderate risk

Vitamin B Complex # 3

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-1024-2016
Class II · Moderate risk

Vitamin B Complex # 1

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-1023-2016
Class II · Moderate risk

Tri-Mix # 6

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-1021-2016
Class II · Moderate risk

Tri-Mix # 5

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-1020-2016
Class II · Moderate risk

Tri-Mix # 4

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-1019-2016
Class II · Moderate risk

Tri-Mix # 3

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-1018-2016
Class II · Moderate risk

Tri-Mix # 2

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-1017-2016
Class II · Moderate risk

Tri-Mix # 1

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Terminated Sterility / contamination Well Care Compounding Pharmacy D-1016-2016

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