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

1,103 recalls, 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

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
Class III · Low risk

Selegiline HCL Tablets USP 5mg

Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples.

Terminated Dissolution failure Stason Pharmaceuticals, Inc. NDC 51862-146-06 D-1479-2016
Class III · Low risk

Lamotrigine Tablets

Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.

Terminated Labeling / mix-up Unichem Pharmaceuticals Usa Inc NDC 29300-113-05 D-1519-2016
Class III · Low risk

Amoxicillin For Oral Suspension

Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.

Terminated Labeling / mix-up West-Ward Pharmaceuticals Corp. NDC 00143-9887-01 D-1515-2016
Class II · Moderate risk

DOBUTamine Injection

Discoloration: Firm received complaints of product discoloration and particulates.

Terminated Failed specification Hospira Inc. NDC 0409-2025-20 D-1500-2016

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