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
Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, ww…
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
Hydralazine HCl Tablets
Class IIIFailed Impurities/Degradation Specifications; during routine stability testing for impurities.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Nov 5, 2024
ZoomMax Capsules
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Boulla LLC · Nov 4, 2024
PeakMax Capsules
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Boulla LLC · Nov 4, 2024
VitalityXtra Capsules
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Boulla LLC · Nov 4, 2024
ZapMax Capsules
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Boulla LLC · Nov 4, 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
IBU (ibuprofen) 600 mg tablets
Class IIIFailed Tablet/Capsule Specifications
Dr. Reddy's Laboratories, Inc. · Oct 29, 2024
Dapsone Gel 7.5%
Class IICrystallization
VIONA PHARMACEUTICALS INC · Oct 29, 2024
Lisdexamfetamine Dimesylate Capsules
Class IIFailed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Lannett Company Inc. · Oct 25, 2024
HealthWise PERIOD PATCH Menstrual Pain Relief
Class IIcGMP Deviations
Unexo Life Sciences Private Limited · Oct 24, 2024
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.