Independent register of U.S. FDA drug recalls · updated Oct 11, 2026
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FDA Drug Recalls

5,405 recalls, newest first

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

Naloxone HCL Preserved INJ

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Terminated Sterility / contamination Premier Pharmacy Labs Inc D-1421-2019
Class II · Moderate risk

Mitomycin Preservative Free Irrigation

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Terminated Sterility / contamination Premier Pharmacy Labs Inc D-1420-2019
Class II · Moderate risk

Lidocaine 0.5%/Phenylephrine 0.75% P.F. INJ

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Terminated Sterility / contamination Premier Pharmacy Labs Inc D-1419-2019
Class II · Moderate risk

Isoproterenol HCL in D5W

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Terminated Sterility / contamination Premier Pharmacy Labs Inc D-1418-2019
Class II · Moderate risk

Isoproterenol HCL in D5W

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Terminated Sterility / contamination Premier Pharmacy Labs Inc D-1417-2019
Class II · Moderate risk

Isoproterenol HCL in D5W

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Terminated Sterility / contamination Premier Pharmacy Labs Inc D-1416-2019
Class II · Moderate risk

Droperidol Injectable Sterile Solution

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Terminated Sterility / contamination Premier Pharmacy Labs Inc D-1415-2019
Class II · Moderate risk

ChlorproMAZINE HCL INJ

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Terminated Sterility / contamination Premier Pharmacy Labs Inc D-1413-2019
Class II · Moderate risk

Brilliant Blue Ophthalmic PF INJ

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Terminated Sterility / contamination Premier Pharmacy Labs Inc D-1412-2019
Class II · Moderate risk

Atropine Sulfate PF INJ

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Terminated Sterility / contamination Premier Pharmacy Labs Inc D-1411-2019

Recalls by year