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
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 Oral Care, LL…
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 co…
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: P…
Class IICGMP Deviations; deficiencies observed during FDA inspection
Dabur India Limited · Jun 2, 2026
Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulf…
Class IICGMP Deviations; deficiencies observed during FDA inspection
Dabur India Limited · Jun 2, 2026
Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfa…
Class IICGMP Deviations; deficiencies observed during FDA inspection
Dabur India Limited · Jun 2, 2026
Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured f…
Class IICGMP Deviations; deficiencies observed during FDA inspection
Dabur India Limited · Jun 2, 2026
Lil Drug Store
Class IICGMP Deviations; deficiencies observed during FDA inspection
Dabur India Limited · Jun 2, 2026
Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured…
Class IICGMP Deviations; deficiencies observed during FDA inspection
Dabur India Limited · Jun 2, 2026
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for:…
Class IICGMP Deviations; deficiencies observed during FDA inspection
Dabur India Limited · Jun 2, 2026
Lucky Super Soft
Class IICGMP Deviations; deficiencies observed during FDA inspection
Dabur India Limited · Jun 2, 2026
Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Ma…
Class IICGMP Deviations; deficiencies observed during FDA inspection
Dabur India Limited · Jun 2, 2026
Lucky Super Soft
Class IICGMP Deviations; deficiencies observed during FDA inspection
Dabur India Limited · Jun 2, 2026
Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units)…
Class IICGMP Deviations; deficiencies observed during FDA inspection
Dabur India Limited · Jun 2, 2026
Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomyc…
Class IICGMP Deviations; deficiencies observed during FDA inspection
Dabur India Limited · Jun 2, 2026
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for…
Class IICGMP Deviations; deficiencies observed during FDA inspection
Dabur India Limited · Jun 2, 2026
Minocycline Hydrochloride Extended-Release Tablets
Class IIFailed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Ascend Laboratories, LLC · Jun 1, 2026
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%
Class IISubpotent drug
Gasco Industrial Corp. · May 29, 2026
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%
Class IISubpotent drug
Gasco Industrial Corp. · May 29, 2026
Gasco Isopropyl Alcohol 70%
Class IISubpotent drug
Gasco Industrial Corp. · May 29, 2026
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%
Class IISubpotent drug
Gasco Industrial Corp. · May 29, 2026
Gasco Isopropyl Alcohol 70%
Class IISubpotent drug
Gasco Industrial Corp. · May 29, 2026
Gasco Isopropyl Alcohol 70%
Class IISubpotent drug
Gasco Industrial Corp. · May 29, 2026
GSMS Incorporated
Class IIFailed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
Golden State Medical Supply Inc. · May 29, 2026
Budesonide Inhalation Suspension
Class IIPresence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
SUN PHARMACEUTICAL INDUSTRIES INC · May 29, 2026
BD ChloraPrep FREPP Clear
Class IILack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
CareFusion 213, LLC · May 28, 2026
Fenofibrate Capsules
Class IICGMP Deviations
Ajanta Pharma USA Inc · May 28, 2026
BD ChloraPrep Clear
Class IILack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
CareFusion 213, LLC · May 28, 2026
KIRKLAND Signature
Class IIPresence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
FAMILY WELLNESS
Class IIPresence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 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.