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
VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams Acti…
Class IIDoes Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
PAI Holdings LLC · May 15, 2026
Duloxetine DR Capsules
Class IICGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Asclemed USA Inc. · May 14, 2026
Estradiol Gel
Class IIDefective Container; packets were found to be either empty or partially full.
ANI Pharmaceuticals, Inc. · May 12, 2026
fentaNYL Citrate
Class IISubpotent Drug
IntegraDose Compounding Services LLC · May 12, 2026
Lidocaine HCl Injection USP
Class IILack of Assurance of Sterility
Spectra Medical Devices, Llc · May 12, 2026
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren…
Class IILabeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Haleon US Holdings LLC · May 11, 2026
cimzia (certolizumab pegol)
Class IILack of Assurance of Sterility
UCB Biosciences Inc. · May 8, 2026
Amlodipine and Olmesartan Medoxomil Tablets
Class IIFailed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Ascend Laboratories, LLC · May 5, 2026
Vitamin B-Complex
Class IIPresence of a Foreign Substance; black particles observed in liquid
Safecor Health, LLC · May 1, 2026
Atomoxetine Capsules HCL
Class IILabeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Safecor Health, LLC · Apr 30, 2026
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Ajanta Pharma Ltd. · Apr 29, 2026
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Ajanta Pharma Ltd. · Apr 29, 2026
Erythromycin Tablets
Class IICGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Zydus Pharmaceuticals (USA) Inc · Apr 29, 2026
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Ajanta Pharma Ltd. · Apr 29, 2026
Erythromycin Tablets
Class IICGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Zydus Pharmaceuticals (USA) Inc · Apr 29, 2026
Ascend Laboratories
Class IIFailed Dissolution Specifications
Ascend Laboratories, LLC · Apr 27, 2026
Oasis Tears PF
Class IILack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
Oasis Medical, Inc. · Apr 27, 2026
Octreotide Acetate for Injectable Suspension
Class IILack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Teva Pharmaceuticals USA, Inc · Apr 24, 2026
Liraglutide Injection
Class IIPresence of particulate matter: a white thread-like structure in the cartridge
Lupin Pharmaceuticals Inc. · Apr 24, 2026
Enalapril Maleate Tablets
Class IIFailed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
JB Chemicals and Pharmaceuticals Ltd · Apr 23, 2026
iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in…
Class IILack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Thea Pharma, Inc. · Apr 23, 2026
Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 m…
Class IILack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Thea Pharma, Inc. · Apr 23, 2026
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alc…
Class IILack of assurance of Sterility: potential product contamination
CareFusion 213, LLC · Apr 22, 2026
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alc…
Class IILack of assurance of Sterility: potential product contamination
CareFusion 213, LLC · Apr 22, 2026
Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in Fran…
Class IILack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Alcon Research LLC · Apr 21, 2026
Duloxetine Delayed-Release Capsules USP
Class IICGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Breckenridge Pharmaceutical, Inc. · Apr 21, 2026
GenTeal Tears
Class IILack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Alcon Research LLC · Apr 21, 2026
Optase Dry Eye Intense Drops (Glycerin 0.2%)
Class IILack of Assurance of Sterility
SCOPE HEALTH · Apr 20, 2026
NAPROXEN ORAL SUSPENSION
Class IIChemical contamination; presence of lead and lithium above specification
Acella Pharmaceuticals, LLC · Apr 20, 2026
FRESHKOTE LUBRICANT EYEDROPS
Class IILack of Assurance of Sterility
Harrow Eye LLC · Apr 17, 2026
Omega-3-Acid
Class IIFailed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
The Harvard Drug Group LLC · Apr 9, 2026
TERPENICOL Antifungal Cream (Undecylenic Acid 13%)
Class IICGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Blaine Labs Inc · Apr 8, 2026
TRIFLUENT PHARMA TRIDERGEL Wound Care Gel
Class IICGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
Blaine Labs Inc · Apr 8, 2026
vite20 Antifungal Cream
Class IICGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Blaine Labs Inc · Apr 8, 2026
Revitaderm Wound Care
Class IICGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Blaine Labs Inc · Apr 8, 2026
TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%)
Class IICGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Blaine Labs Inc · Apr 8, 2026
Fungal Fusion ERADICATION Solution
Class IICGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Blaine Labs Inc · Apr 8, 2026
TERPENICOL Antifungal Solution
Class IICGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Blaine Labs Inc · Apr 8, 2026
Desmopressin Nasal Spray
Class IIDefective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Apotex Corp. · Apr 8, 2026
Alendronate Sodium Oral Solution
Class IIThis recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Hikma Pharmaceuticals USA INC · Apr 7, 2026
Showing 40 of 1,472 Class II recalls (1,769 tracked in total).
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.