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

Marcaine 0.5%

Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.

Terminated Sterility / contamination Hospira Inc., A Pfizer Company NDC 0409-1610-50 D-0097-2017
Class II · Moderate risk

Marcaine 0.25%

Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.

Terminated Sterility / contamination Hospira Inc., A Pfizer Company NDC 0409-1587-50 D-0096-2017
Class II · Moderate risk

Desoximetasone Cream USP

Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).

Terminated Stability / shelf life Taro Pharmaceuticals, Inc. NDC 51672-1271-7 D-0117-2017
Class II · Moderate risk

Desoximetasone Cream USP

Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).

Terminated Stability / shelf life Taro Pharmaceuticals, Inc. NDC 51672-1270-7 D-0116-2017
Class II · Moderate risk

Tri-Mix 18/1/10

Lack of Assurance of Sterility; medication was sterilized with a recalled filter

Terminated Sterility / contamination The Apothecary Shoppe LLC D-0004-2017
Class II · Moderate risk

Eye Wash

Lack of assurance of sterility

Terminated Sterility / contamination United Exchange Corporation NDC 0904-6491-20 D-0499-2017
Class II · Moderate risk

Phenylephrine HCI Injection

Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.

Terminated Sterility / contamination Sandoz Inc NDC 66758-016-03 D-1514-2016
Class II · Moderate risk

Ephedrine Sulfate Injection

Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.

Terminated Sterility / contamination Sandoz Inc NDC 66758-008-01 D-1513-2016
Class II · Moderate risk

Dextroamphetamine Saccharate

Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule

Terminated Labeling / mix-up Amerisource Health Services NDC 68084-887-32 D-1490-2016
Class II · Moderate risk

Dextroamphetamine Saccharate

Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule

Terminated Labeling / mix-up Amerisource Health Services NDC 68084-909-32 D-1489-2016
Class II · Moderate risk

Dextroamphetamine Saccharate

Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule

Terminated Labeling / mix-up Amerisource Health Services NDC 68084-832-25 D-1488-2016
Class II · Moderate risk

Dextroamphetamine Saccharate

Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule

Terminated Labeling / mix-up Amerisource Health Services NDC 68084-898-32 D-1487-2016
Class II · Moderate risk

Dextroamphetamine Saccharate

Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule

Terminated Labeling / mix-up Amerisource Health Services NDC 68084-815-25 D-1486-2016
Class II · Moderate risk

Dextroamphetamine Saccharate

Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule

Terminated Labeling / mix-up Amerisource Health Services NDC 60687-154-25 D-1485-2016
Class II · Moderate risk

Dextroamphetamine Saccharate

Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule

Terminated Labeling / mix-up Amerisource Health Services NDC 68084-943-25 D-1484-2016
Class II · Moderate risk

Dextroamphetamine Saccharate

Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule

Terminated Labeling / mix-up Amerisource Health Services NDC 60687-133-25 D-1483-2016
Class II · Moderate risk

Dextroamphetamine Saccharate

Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule

Terminated Labeling / mix-up Amerisource Health Services NDC 68084-936-25 D-1482-2016
Class II · Moderate risk

Dextroamphetamine Saccharate

Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule

Terminated Labeling / mix-up Amerisource Health Services NDC 68084-874-25 D-1481-2016
Class II · Moderate risk

Transderm Scop

Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.

Terminated Packaging defect Sandoz Inc D-0133-2017

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