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

1,525 recalls · Class III, 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

Tarina Fe 1/20

Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.

Terminated Chemical / undeclared Mylan Pharmaceuticals Inc. NDC 50102-128-01 D-0860-2017
Class III · Low risk

Buffered Lidocaine

Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9%

Terminated Labeling / mix-up Pharmedium Services, LLC D-0603-2017
Class III · Low risk

Dexamethasone Elixir

Failed Impurities/ Degradation Specifications

Terminated Impurity / degradation Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals NDC 0603-1147-56 D-0438-2017
Class III · Low risk

Montelukast sodium tablets

Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.

Terminated Failed specification Hetero USA Inc NDC 31722-726-30 D-0623-2017
Class III · Low risk

Donepezil HCl tablets

Supotent: Out of Specification result for assay test during routine stability testing.

Terminated Wrong potency / content Mckesson Packaging Services NDC 63739-678-10 D-0680-2017
Class III · Low risk

Finasteride Tablets

Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.

Terminated Failed specification Hetero Drugs Ltd. - Unit 1 NDC 31722-525-90 D-0453-2017
Class III · Low risk

Aripiprazole Tablets

Superpotent Drug; out of specification results for assay (manufacturer)

Terminated Wrong potency / content The Harvard Drug Group NDC 0904-6509-04 D-0692-2017
Class III · Low risk

Azelastine Hydrochloride Nasal Solution

Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..

Terminated Packaging defect Roxane Laboratories, Inc. NDC 0054-0293-99 D-0448-2017
Class III · Low risk

VirtPrex Prenatal/Postnatal Tablets

cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.

Terminated cGMP deviation Virtus Pharmaceuticals Opco II L NDC 76439-348-30 D-0241-2017
Class III · Low risk

Pentasa (mesalamine)

Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules

Terminated Particulate / foreign matter Shire PLC NDC 54092-189-81 D-0432-2017

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