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

1,586 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2019 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
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
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
Class II · Moderate risk

Losartan Potassium

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Terminated Nitrosamine impurity Golden State Medical Supply Inc. NDC 60429-318-90 D-1465-2019
Class II · Moderate risk

Losartan Potassium

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Terminated Nitrosamine impurity Golden State Medical Supply Inc. NDC 60429-317-10 D-1464-2019
Class II · Moderate risk

Losartan Potassium

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Terminated Nitrosamine impurity Golden State Medical Supply Inc. NDC 60429-317-90 D-1463-2019
Class II · Moderate risk

Losartan Potassium

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Terminated Nitrosamine impurity Golden State Medical Supply Inc. NDC 60429-317-30 D-1462-2019
Class II · Moderate risk

Sevoflurane

Failed Stability Specifications

Terminated Stability / shelf life Baxter Healthcare Corporation NDC 10019-651-64 D-1435-2019
Class II · Moderate risk

Heparin Sodium 25

Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potency which is intended to ensure that the potency of heparin is within the USP specifications.

Terminated Wrong potency / content B. Braun Medical Inc NDC 0264-9587-20 D-1343-2019

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