Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II drug recalls - moderate risk

Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.

14,535 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

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

Children's Acetaminophen Oral Suspension

Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of acetaminophen contained within it, is an adult dose.

Terminated Labeling / mix-up Precision Dose Inc. NDC 68094-650-59 D-250-2013
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
Class II · Moderate risk

Test cyp 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-673-2013
Class II · Moderate risk

Test cyp 35 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-672-2013
Class II · Moderate risk

Test Cyp 25 mg-e

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

Terminated Sterility / contamination Clinical Specialties Compounding Pharmacy D-671-2013

Recalls by year