Independent register of U.S. FDA drug recalls · updated Oct 14, 2026
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Class II drug recalls - moderate risk

Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.

14,543 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

Avastin

Lack of Assurance of Sterility

Terminated Sterility / contamination RXQ Compounding LLC NDC 70731-0197-91 D-1637-2019
Class II · Moderate risk

SUCCINYLcholine Chloride

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-1428-2019
Class II · Moderate risk

SUCCINYLcholine Chloride

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-1427-2019
Class II · Moderate risk

Sodium Bicarbonate INJ 8.4%

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-1426-2019
Class II · Moderate risk

Riboflavin 5-Phosphate Sodium Ophthalmic 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-1425-2019
Class II · Moderate risk

Phenylephrine HCL PF INJ in 0.9% Sodium Chloride

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-1424-2019
Class II · Moderate risk

Neostigmine Methylsulfate

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-1422-2019
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

Recalls by year