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
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…
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 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 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
ChloraPrep FREPP
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
Gemcitabine Injection
Class IITemperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
McKesson · Jun 10, 2026
IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single…
Class IILack of assurance of Sterility:
ACCORD BIOPHARMA INC · Jun 10, 2026
Lidocaine HCl Injection USP
Class IILack of Assurance of Sterility
Asclemed USA Inc. · Jun 8, 2026
Levothyroxine Sodium Tablets
Class IISubpotent Drug
ACCORD HEALTHCARE, INC. · Jun 8, 2026
Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL…
Class IILack of Assurance of Sterility
Asclemed USA Inc. · Jun 8, 2026
Methohexital Sodium for Injection
Class IIFailed Impurities/Degradation Specifications
ONESOURCE SPECIALTY PHARMA LIMITED · Jun 7, 2026
Chlorthalidone Tablets
Class IIFailed Dissolution Specifications
Inventia Healthcare Limited · Jun 5, 2026
prednisoLONE Acetate Ophthalmic Suspension
Class IIPresence of Foreign Substance
Lupin Pharmaceuticals Inc. · Jun 4, 2026
Sensipar (cinacalcet) Tablets
Class IICGMP Deviations
Amgen, Inc. · Jun 4, 2026
Sensipar (cinacalcet) Tablets
Class IICGMP Deviations
Amgen, Inc. · Jun 4, 2026
Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Care, LLC…
Class IIsub potency
Elevate Oral Care · Jun 4, 2026
Sensipar (cinacalcet) Tablets
Class IICGMP Deviations
Amgen, Inc. · Jun 4, 2026
Corlanor (ivabradine) tablets
Class IIPresence of Foreign Substance.
Amgen, Inc. · Jun 4, 2026
Corlanor (ivabradine) tablets
Class IIPresence of Foreign Substance.
Amgen, Inc. · Jun 4, 2026
Lacosamide Tablets
Class IIPresence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
Annora Pharma Private Limited · Jun 4, 2026
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc. · Jun 4, 2026
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc. · Jun 4, 2026
Total Parental Nutrition
Class IIIncorrect product formulation: bag did not contain copper and famotidine per label.
Central Admixture Pharmacy Services, Inc. · Jun 2, 2026
Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144…
Class IICGMP Deviations; deficiencies observed during FDA inspection
Dabur India Limited · Jun 2, 2026
Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por…
Class IICGMP Deviations; deficiencies observed during FDA inspection
Dabur India Limited · Jun 2, 2026
Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin…
Class IICGMP Deviations; deficiencies observed during FDA inspection
Dabur India Limited · Jun 2, 2026
Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin…
Class IICGMP Deviations; deficiencies observed during FDA inspection
Dabur India Limited · Jun 2, 2026
Showing 40 of 1,576 Class II recalls (1,895 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.