Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class I drug recalls - the high-risk category

Class I is the FDA's most serious recall category: a reasonable probability that using the product will cause serious health consequences or death. It is a small share of all recalls, but the one to check first if a medication you take appears here.

1,750 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 I · High risk

Tetracycline HCL Capsules

Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.

Terminated Dissolution failure Avet Pharmaceuticals, Inc. NDC 23155-018-01 D-1254-2020
Class I · High risk

Phytonadione Injectable Emulsion

Defective Container: Recall is due to breaking and shattering of ampules upon opening

Terminated Packaging defect Dr. Reddy's Laboratories, Inc. NDC 43598-405-11 D-1094-2020
Class I · High risk

Phenytoin Oral Suspension USP

Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.

Terminated Failed specification Taro Pharmaceuticals U.S.A., Inc. NDC 51672-4069-1 D-0863-2020
Class I · High risk

Ketorolac Trom

Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine visual inspection. of retain samples.

Terminated Particulate / foreign matter RemedyRepack Inc. NDC 70518-1239-00 D-0867-2020
Class I · High risk

Lamotrigine Tablets

Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.

Terminated Cross-contamination Taro Pharmaceuticals U.S.A., Inc. NDC 51672-4131-1 D-0833-2020
Class I · High risk

Mirtazapine Tablets

Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.

Terminated Labeling / mix-up AuroMedics Pharma LLC NDC 13107-001-05 D-0637-2020
Class I · High risk

Mirtazapine Tablets

Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.

Terminated Labeling / mix-up AuroMedics Pharma LLC NDC 13107-031-05 D-0636-2020
Class I · High risk

Silver Bullet

Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.

Terminated Chemical / undeclared Natures Rx D-0633-2020
Class I · High risk

Bow & Arrow

Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.

Terminated Chemical / undeclared Med Man Distribution, Inc. D-1037-2020
Class I · High risk

UP2, Dietary Supplement

Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.

Terminated Chemical / undeclared Med Man Distribution, Inc. D-1036-2020
Class I · High risk

Green Lumber Natural Fuel For Men capsule

Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.

Terminated Chemical / undeclared Green Lumber Holdings, LLC D-0351-2020
Class I · High risk

Natpara (parathyroid hormone)

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

Terminated Packaging defect Shire Human Genetic Therapies, Inc. D-0038-2020
Class I · High risk

Natpara (parathyroid hormone)

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

Terminated Packaging defect Shire Human Genetic Therapies, Inc. NDC 68875-0204-02 D-0037-2020
Class I · High risk

Natpara (parathyroid hormone)

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

Terminated Packaging defect Shire Human Genetic Therapies, Inc. NDC 68875-0203-02 D-0036-2020
Class I · High risk

Natpara (parathyroid hormone)

Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing

Terminated Packaging defect Shire Human Genetic Therapies, Inc. NDC 68875-0202-02 D-0035-2020

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