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

5% Dextrose Injection

Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)

Terminated Particulate / foreign matter Baxter Healthcare Corp. NDC 0338-0017-02 D-1209-2015
Class I · High risk

Lactated Ringer's Irrigation

Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold

Terminated Sterility / contamination Hospira Inc. NDC 0409-7828-08 D-1108-2015
Class I · High risk

Ultra Zx Dietary Supplement

Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein

Terminated Chemical / undeclared Ultra ZX Supplements D-0991-2015
Class I · High risk

Magnesium Sulfate in 5% Dextrose Injection

Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9% in sodium chloride injection.

Terminated Labeling / mix-up Hospira Inc. NDC 0409-6727-23 D-1076-2015
Class I · High risk

PHENYLephrine HCl

Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).

Terminated Particulate / foreign matter Pharmedium Services, LLC NDC 61553-149-50 D-1828-2015
Class I · High risk

PHENYLephrine HCl

Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).

Terminated Particulate / foreign matter Pharmedium Services, LLC NDC 61553-236-50 D-1827-2015
Class I · High risk

PHENYLephrine HCl

Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).

Terminated Particulate / foreign matter Pharmedium Services, LLC NDC 61553-156-50 D-1826-2015
Class I · High risk

Fentanyl Citrate

Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).

Terminated Particulate / foreign matter Pharmedium Services, LLC NDC 61553-107-50 D-1825-2015
Class I · High risk

Morphine Sulfate

Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).

Terminated Particulate / foreign matter Pharmedium Services, LLC NDC 61553-181-50 D-1824-2015
Class I · High risk

Bupivacaine HCl 0.0625%

Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).

Terminated Particulate / foreign matter Pharmedium Services, LLC NDC 61553-197-50 D-1823-2015
Class I · High risk

PHENYLephrine HCl

Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).

Terminated Particulate / foreign matter Pharmedium Services, LLC NDC 61553-169-50 D-1822-2015
Class I · High risk

PHENYLephrine HCl

Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).

Terminated Particulate / foreign matter Pharmedium Services, LLC NDC 61553-171-50 D-1821-2015
Class I · High risk

iNSANE Bee Pollen capsules

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making iNSANE an unapproved drug.

Terminated Chemical / undeclared Detox Transforms D-0981-2015
Class I · High risk

BtRiM Max capsules

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making BtRiM Max an unapproved drug.

Terminated Chemical / undeclared Detox Transforms D-0980-2015
Class I · High risk

AMPD GOLD Bee Pollen capsules

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, making AMPD GOLD an unapproved drug.

Terminated Chemical / undeclared Detox Transforms D-0979-2015
Class I · High risk

iNDiGO capsules

Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making iNDiGO an unapproved drug.

Terminated Chemical / undeclared Detox Transforms D-0978-2015

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