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
Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30…
Class IICGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Keystone Industries · Nov 14, 2024
safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz…
Class IICGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Keystone Industries · Nov 14, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Amerisource Health Services LLC · Nov 14, 2024
Quala Dental Products
Class IICGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Keystone Industries · Nov 14, 2024
Henry Schein
Class IICGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Keystone Industries · Nov 14, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Amerisource Health Services LLC · Nov 14, 2024
Gelato, Benzocaine 20% Topical Gel Anesthetic Net Wt. 1 oz. (30ml)…
Class IICGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Keystone Industries · Nov 14, 2024
Kissable Diabetics Foot Cream
Class IICGMP Deviations: lack of adequate release testing.
Brands International Corporation · Nov 13, 2024
Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box…
Class IIcGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Safecor Health, LLC · Nov 11, 2024
Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box…
Class IIcGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Safecor Health, LLC · Nov 11, 2024
Venofer (iron sucrose) Injection
Class IIPresence of Particulate Matter: Potential for glass delamination from the vials.
American Regent, Inc. · Nov 11, 2024
Docusate Sodium 250 mg
Class IIcGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Safecor Health, LLC · Nov 11, 2024
Calcium Carbonate Chewable 500 mg
Class IIcGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Safecor Health, LLC · Nov 11, 2024
Aspirin Chewable tablet 81 mg
Class IIcGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Safecor Health, LLC · Nov 11, 2024
Venofer (iron sucrose) Injection
Class IIPresence of Particulate Matter: Potential for glass delamination from the vials.
American Regent, Inc. · Nov 11, 2024
Venofer (iron sucrose) Injection
Class IIPresence of Particulate Matter: Potential for glass delamination from the vials.
American Regent, Inc. · Nov 11, 2024
Levothyroxine Sodium Tablets
Class IISubpotent drug
ACCORD HEALTHCARE, INC. · Nov 8, 2024
Cinacalcet Tablets
Class IIcGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Aurobindo Pharma USA Inc · Nov 7, 2024
Guaifenesin Dextromethorphan Syrup
Class IIFailed Impurity/Degradation Specifications
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Nov 7, 2024
Cinacalcet Tablets
Class IIcGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Aurobindo Pharma USA Inc · Nov 7, 2024
Guaifenesin Dextromethorphan Syrup
Class IIFailed Impurity/Degradation Specifications
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Nov 7, 2024
Cinacalcet Tablets
Class IIcGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Aurobindo Pharma USA Inc · Nov 7, 2024
MAXIM Assure Antibacterial
Class IIcGMP Deviations: Out of specification results for micro in hand soap products.
Midlab Incorporated · Nov 6, 2024
Trinity Gold Nutrition
Class IIMarketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
Trinity Gold Nutrition · Nov 6, 2024
Genuine Joe Antibacterial Lotion Soap
Class IIcGMP Deviations: Out of specification results for micro in hand soap products.
Midlab Incorporated · Nov 6, 2024
Compliance Dishwashing Liquid & Antibacterial Soap
Class IIcGMP Deviations: Out of specification results for micro in hand soap products.
Midlab Incorporated · Nov 6, 2024
boardwalk ANTIBACTERIAL HANDSOAP REFILL
Class IIcGMP Deviations: Out of specification results for micro in hand soap products.
Midlab Incorporated · Nov 6, 2024
BEVACIZUMAB (AVASTIN)1.25mg/0.05mL
Class IILack of Sterility Assurance
Tailstorm Health INC · Nov 6, 2024
Array Liquid Antiseptic Handwash
Class IIcGMP Deviations: Out of specification results for micro in hand soap products.
Midlab Incorporated · Nov 6, 2024
ROYALAB Germ Away Antibacterial Hand Soap
Class IIcGMP Deviations: Out of specification results for micro in hand soap products.
Midlab Incorporated · Nov 6, 2024
Cooling Menthol Extra Strength Pain Relief Patch
Class IIcGMP Deviations
JR Watkins · Nov 1, 2024
Diltiazem Hydrochloride Extended-Release Capsules
Class IIcGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Glenmark Pharmaceuticals Inc., USA · Nov 1, 2024
Diltiazem Hydrochloride Extended-Release Capsules
Class IIcGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Glenmark Pharmaceuticals Inc., USA · Nov 1, 2024
Diltiazem Hydrochloride Extended-Release Capsules
Class IIcGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Glenmark Pharmaceuticals Inc., USA · Nov 1, 2024
Diltiazem Hydrochloride Extended-Release Capsules
Class IIcGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Glenmark Pharmaceuticals Inc., USA · Nov 1, 2024
Diltiazem Hydrochloride Extended-Release Capsules
Class IIcGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Glenmark Pharmaceuticals Inc., USA · Nov 1, 2024
Diltiazem Hydrochloride Extended-Release Capsules
Class IIcGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Glenmark Pharmaceuticals Inc., USA · Nov 1, 2024
Xelstrym (dextroamphetamine) transdermal system
Class IIDefective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Noven Pharmaceuticals Inc · Oct 31, 2024
Regadenoson Injection
Class IILabeling: Missing Label
Baxter Healthcare Corporation · Oct 30, 2024
Timolol Maleate Ophthalmic Solution USP
Class IIDefective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
FDC Limited · Oct 29, 2024
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.