Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts

Class III drug recalls - low risk

Class III means the product is unlikely to cause harm but violates FDA labeling or manufacturing rules. These are the recalls you rarely hear about; pharmacies usually just swap the affected lot.

1,716 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 III · Low risk

Ampicillin Capsules

Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.

Terminated Labeling / mix-up Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals D-1350-2015
Class III · Low risk

Topicort (desoximetasone)

Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.

Terminated Impurity / degradation Taro Pharmaceuticals, Inc. D-1370-2015
Class III · Low risk

Dexmethylphenidate HCl Extended-Release

Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.

Terminated Dissolution failure Novartis Pharmaceuticals Corp. D-1430-2015
Class III · Low risk

Hydralazine Hydrochloride Injection

Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)

Terminated Stability / shelf life Fresenius Kabi USA, LLC NDC 63323-614-01 D-1327-2015

Recalls by year