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
Aripiprazole Tablets USP
Class IIProduct Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Ajanta Pharma USA Inc · May 27, 2026
Niacin Extended-release Tablets
Class IIFailed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Lannett Company Inc. · May 27, 2026
Xyvona (levorphanol tartrate tablets)
Class IILabeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
SUN PHARMACEUTICAL INDUSTRIES INC · May 22, 2026
Xyvona (levorphanol tartrate tablets)
Class IILabeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
SUN PHARMACEUTICAL INDUSTRIES INC · May 22, 2026
Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, M…
Class IIMicrobial contamination of sterile products
Zep Inc · May 22, 2026
Pearson Quality Topical Anesthetic Gel (20% Benzocaine)
Class IIDefective container:may contain bottles with incomplete seals
Keystone Industries · May 21, 2026
safco SensiCaine-Ultra (20% Benzocaine)
Class IIDefective container:may contain bottles with incomplete seals
Keystone Industries · May 21, 2026
Dental City TOPICAL ANESTHETIC GEL
Class IIDefective container:may contain bottles with incomplete seals
Keystone Industries · May 21, 2026
Burkhart topical anesthetic gel
Class IIDefective container:may contain bottles with incomplete seals
Keystone Industries · May 21, 2026
Quala Dental Products
Class IIDefective container:may contain bottles with incomplete seals
Keystone Industries · May 21, 2026
PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavo…
Class IIDefective container:may contain bottles with incomplete seals
Keystone Industries · May 21, 2026
DHP Topical Anesthetic Gel
Class IIDefective container:may contain bottles with incomplete seals
Keystone Industries · May 21, 2026
Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9)
Class IIcGMP deviations
Shimoga Chemicals · May 19, 2026
PReye Vitamin See Antioxidant Preservative Free Eye Drops
Class IILack of Assurance of Sterility
PReye LLC · May 18, 2026
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride
Class IISubpotent Drug
IntegraDose Compounding Services LLC · May 18, 2026
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Steril…
Class IIIFailed Stability Specifications
AbbVie Inc. · May 18, 2026
Lidocaine HCl Injection
Class IIILabeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Eugia US LLC · May 18, 2026
VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams Act…
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
VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 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
VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 25 Grams Act…
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
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
Epinephrine Injection
Class IIIFailed Impurities/Degradations Specifications
Fresenius Kabi USA, LLC · May 14, 2026
Nicotine Transdermal System Patch
Class IIIFailed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
AVEVA Drug Delivery Systems, 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
DOXOrubin Hydrochloride Liposome injection
Class IPresence of Particulate matter: Particulate matter identified as glass.
SUN PHARMACEUTICAL INDUSTRIES 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
Busulfan Injection
Class IIIFailed Impurities/Degradation Specifications
Sagent Pharmaceuticals · May 4, 2026
Vitamin B-Complex
Class IIPresence of a Foreign Substance; black particles observed in liquid
Safecor Health, LLC · May 1, 2026
Primidone Tablets
Class IIICross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Amerisource Health Services LLC · May 1, 2026
Primidone Tablets
Class IIICross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Amerisource Health Services 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
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.