Class II · Moderate risk
Dextroamphetamine Saccharate
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
FDA drug recalls in 2026
Every FDA drug recall initiated in 2026, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
563 recalls, newest first.
Class II · Moderate risk
CAREone
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
meijer
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
Foster & Thrive
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
Leader
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
Good Neighbor Pharmacy
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
FAMILY Wellness
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
Audiologist's Choice
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
TopCare Health
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
QC Quality Choice
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
Clinere
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class II · Moderate risk
CVS Health
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Class I · High risk
Cetirizine Hydrochloride Tablets USP 5 mg
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
Class II · Moderate risk
Azacitidine for Injection 100mg/Vial
Lack of Sterility Assurance
Class II · Moderate risk
Bortezomib for Injection 3.5mg/Vial
Lack of Sterility Assurance
Class II · Moderate risk
Pemetrexed for Injection 500mg/Vial
Lack of Sterility Assurance
Class II · Moderate risk
Pemetrexed for Injection 100mg/Vial
Lack of Sterility Assurance
Class II · Moderate risk
Methohexital Sodium
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Glucagon Emergency Kit for Low Blood Sugar
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Class II · Moderate risk
Nystatin Cream USP
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Class II · Moderate risk
Duloxetine D/R
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk
Perampanel CIII Tablets
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Class II · Moderate risk
Carton Label: MAJOR
Subpotent Drug
Class II · Moderate risk
Synjardy XR Tablets
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
Class II · Moderate risk
Buprenorphine HCl
Crystallization; identified as Buprenorphine free base