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

Daptomycin

CGMP Deviations

Ongoing cGMP deviation Baxter Healthcare Corporation NDC 0338-0714-24 D-0807-2026
Class II · Moderate risk

Myxredlin

CGMP Deviations

Ongoing cGMP deviation Baxter Healthcare Corporation NDC 0338-0126-12 D-0806-2026
Class II · Moderate risk

Acthar Gel

Presence of particulate matter: glass and stopper piece

Ongoing Particulate / foreign matter Mallinckrodt Hospital Products Inc. NDC 63004-8710-1 D-0803-2026
Class II · Moderate risk

Diovan (valsartan)

Failed Dissolution Specifications

Ongoing Dissolution failure Novartis Pharmaceuticals Corporation NDC 0078-0359-34 D-0746-2026
Class II · Moderate risk

Carbamazepine Tablets

CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing

Ongoing cGMP deviation Sun Pharmaceutical Industries INC NDC 51672-4005-3 D-0770-2026
Class II · Moderate risk

Sildenafil Citrate USP

CGMP Deviations:Noted during FDA inspection

Ongoing cGMP deviation Shoolin Pharma Chem LLP NDC 85702-001-08 D-0763-2026
Class II · Moderate risk

Tadalafil USP

CGMP Deviations:Noted during FDA inspection

Ongoing cGMP deviation Shoolin Pharma Chem LLP NDC 85702-001-08 D-0762-2026
Class II · Moderate risk

Tadalafil USP

CGMP Deviations:Noted during FDA inspection

Ongoing cGMP deviation Shoolin Pharma Chem LLP NDC 85702-002-04 D-0761-2026

Recalls by year