FDA drug recalls
The latest medications recalled in the U.S., straight from the FDA's openFDA Enforcement database — what was recalled, why, and how serious it is. Informational only; for any product you have, follow the FDA's guidance and ask your pharmacist.
Subscribe to the recall feed (RSS) — every new recall as it lands, with the FDA's own stated reason.
Recalls by drug type
CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL)
Class IILack of Assurance of Sterility
Chiesi USA, Inc. · Jul 6, 2026
Mycophenolate Mofetil for Injection USP
Class IIPresence of precipitate
MYLAN PHARMACEUTICALS INC · Jul 2, 2026
Dabigatran etexilate Capsules
Class IIIFailed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Ascend Laboratories, LLC · Jun 30, 2026
Dabigatran etexilate Capsules
Class IIIFailed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Ascend Laboratories, LLC · Jun 30, 2026
Cinacalcet Hydrochloride Tablets
Class IIcGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Cipla USA, Inc. · Jun 29, 2026
Cinacalcet Hydrochloride Tablets
Class IIcGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Cipla USA, Inc. · Jun 29, 2026
Cinacalcet Hydrochloride Tablets
Class IIcGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Cipla USA, Inc. · Jun 29, 2026
Divalproex Sodium Delayed-Release Tablets
Class IIPresence of Foreign Tablets/Capsules
Bionpharma Inc. · Jun 26, 2026
Dextroamphetamine Saccharate
Class IILabeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Lannett Company Inc. · Jun 26, 2026
Foster & Thrive
Class IISubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Bell Pharmaceuticals, Inc · Jun 25, 2026
GOOD NEIGHBOR PHARMACY
Class IISubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Bell Pharmaceuticals, Inc · Jun 25, 2026
AUDIOLOGIST'S CHOICE
Class IISubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Bell Pharmaceuticals, Inc · Jun 25, 2026
TopCare Health
Class IISubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Bell Pharmaceuticals, Inc · Jun 25, 2026
CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-82…
Class IISubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Bell Pharmaceuticals, Inc · Jun 25, 2026
meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41…
Class IISubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Bell Pharmaceuticals, Inc · Jun 25, 2026
CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, D…
Class IISubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Bell Pharmaceuticals, Inc · Jun 25, 2026
FAMILY Wellness
Class IISubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Bell Pharmaceuticals, Inc · Jun 25, 2026
LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRING…
Class IISubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Bell Pharmaceuticals, Inc · Jun 25, 2026
Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.5…
Class IISubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Bell Pharmaceuticals, Inc · Jun 25, 2026
QC Quality Choice
Class IISubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Bell Pharmaceuticals, Inc · Jun 25, 2026
Cetirizine Hydrochloride Tablets USP 5 mg
Class ICross 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.
JB Chemicals and Pharmaceuticals Ltd · Jun 24, 2026
Methohexital Sodium
Class IIFailed Impurities/Degradation Specifications
QuVa Pharma, Inc. · Jun 24, 2026
Azacitidine for Injection 100mg/Vial
Class IILack of Sterility Assurance
Reliance Life Sciences Private Limited · Jun 24, 2026
Pemetrexed for Injection 100mg/Vial
Class IILack of Sterility Assurance
Reliance Life Sciences Private Limited · Jun 24, 2026
Bortezomib for Injection 3.5mg/Vial
Class IILack of Sterility Assurance
Reliance Life Sciences Private Limited · Jun 24, 2026
Pemetrexed for Injection 500mg/Vial
Class IILack of Sterility Assurance
Reliance Life Sciences Private Limited · Jun 24, 2026
Nystatin Cream USP
Class IISubpotent Drug: Low out of specification assay results performed during long-term stability testing.
Padagis US LLC · Jun 23, 2026
Glucagon Emergency Kit for Low Blood Sugar
Class IICGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Lupin Pharmaceuticals Inc. · Jun 23, 2026
DULOXETINE D/R
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Direct Rx · Jun 22, 2026
Perampanel CIII Tablets
Class IILabeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
SUN PHARMACEUTICAL INDUSTRIES INC · Jun 17, 2026
Carton Label: MAJOR
Class IISubpotent Drug
The Harvard Drug Group LLC · Jun 16, 2026
Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release…
Class IICGMP 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.
Boehringer Ingelheim Pharmaceuticals, Inc. · Jun 12, 2026
Buprenorphine HCl
Class IICrystallization; identified as Buprenorphine free base
Par Health USA, LLC · Jun 12, 2026
Medline Remedy Specialized Silicone Cream (Hydraguard-D )
Class IIFailed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
BioMed Laboratories, LLC. · Jun 11, 2026
BD ChloraPrep Clear
Class IILack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
CareFusion 213, LLC · Jun 11, 2026
BD ChloraPrep Hi-Lite Orange
Class IILack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
CareFusion 213, LLC · Jun 11, 2026
BD ChloraPrep Scrub Teal
Class IILack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
CareFusion 213, LLC · Jun 11, 2026
BD ChloraPrep Hi-Lite Orange
Class IILack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
CareFusion 213, LLC · Jun 11, 2026
BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl a…
Class IILack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
CareFusion 213, LLC · Jun 11, 2026
BD ChloraPrep Scrub Teal
Class IILack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
CareFusion 213, LLC · Jun 11, 2026
Showing 40 of 1,769 recalls tracked.
Related: which FDA-approved drugs are no longer marketed — our discontinued-drugs report →
What the recall classes mean
- Class I
- Most serious — a reasonable probability that use will cause serious harm or death.
- Class II
- May cause temporary or medically reversible harm; low probability of serious harm.
- Class III
- Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Data source: U.S. FDA openFDA Drug Enforcement Reports. This page reproduces FDA recall data for reference and is not medical advice. Always follow the FDA's and your pharmacist's guidance.