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

5,405 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 II · Moderate risk

Tacrolimus Ophthalmic

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-875-2013
Class II · Moderate risk

Quadmix Injection

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-874-2013
Class II · Moderate risk

Nandrolone Decanoate Injectable

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-873-2013
Class II · Moderate risk

MIC with B6 and B12

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-872-2013
Class II · Moderate risk

Methylcobalamin PF

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-871-2013
Class II · Moderate risk

Hydroxyprogesterone CAPR.

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-870-2013
Class II · Moderate risk

HCG Chorionic Gonadotropin

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-869-2013
Class II · Moderate risk

Gentamicin Sulfate Irrigation

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-868-2013
Class II · Moderate risk

DMSO Aqueous Irrigation 50%

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-867-2013
Class II · Moderate risk

Dexamethasone PF

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-866-2013
Class II · Moderate risk

Diazepam Injectable

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-865-2013
Class II · Moderate risk

Cyclosporine Ophthalmic

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-864-2013
Class II · Moderate risk

Cidofovir Opthalmic Solution

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-863-2013
Class II · Moderate risk

BiMix Injection

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-861-2013
Class II · Moderate risk

Bacteriostatic Water for Injection

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-860-2013
Class II · Moderate risk

Atropine Injection

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-859-2013
Class II · Moderate risk

Alprostadil IN NS Injection

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-858-2013
Class II · Moderate risk

Acetylcysteine Ophthalmic Solution

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Pallimed Solutions D-857-2013
Class II · Moderate risk

Vancomycin 50 mg/ml

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Terminated Sterility / contamination Clinical Specialties Compounding Pharmacy D-680-2013
Class II · Moderate risk

Tetracaine

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Terminated Sterility / contamination Clinical Specialties Compounding Pharmacy D-679-2013

Recalls by year