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
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
ABSORBINE JR PAIN RELIEVING KNEE PATCH
Class IIcGMP Deviations
Unexo Life Sciences Private Limited · Oct 24, 2024
CHEEKY BONSAI PAIN RELIEF PATCHES
Class IIcGMP Deviations
Unexo Life Sciences Private Limited · Oct 24, 2024
ABSORBINE jr ULTRA STRENGTH PAIN PATCH
Class IIcGMP Deviations
Unexo Life Sciences Private Limited · Oct 24, 2024
JR WATKINS COOLING PAIN RELIEF PATCHES
Class IIcGMP Deviations
Unexo Life Sciences Private Limited · Oct 24, 2024
EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH 4% Topical Anesthetic
Class IIcGMP Deviations
Unexo Life Sciences Private Limited · Oct 24, 2024
LILAS Feminine Pain Relief Patch
Class IIcGMP Deviations
Unexo Life Sciences Private Limited · Oct 24, 2024
THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH
Class IIcGMP Deviations
Unexo Life Sciences Private Limited · Oct 24, 2024
PARCHE LEON PAIN RELIEVING HOT PATCH
Class IIcGMP Deviations
Unexo Life Sciences Private Limited · Oct 24, 2024
ABSORBINE jr. Extra Large BACK PATCH
Class IIcGMP Deviations
Unexo Life Sciences Private Limited · Oct 24, 2024
THERACARE Cold Hot Medicated Patch
Class IIcGMP Deviations
Unexo Life Sciences Private Limited · Oct 24, 2024
Lanthanum Carbonate Chewable Tablets
Class IIFailed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Cipla USA, Inc. · Oct 23, 2024
Lanthanum Carbonate Chewable Tablets
Class IIFailed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Cipla USA, Inc. · Oct 23, 2024
Ramipril Capsules USP 5 mg
Class IICGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Lupin Pharmaceuticals Inc. · Oct 23, 2024
Ramipril Capsules USP 2.5 mg
Class IICGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Lupin Pharmaceuticals Inc. · Oct 23, 2024
Ramipril Capsules USP 10 mg
Class IICGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Lupin Pharmaceuticals Inc. · Oct 23, 2024
Morphine Sulfate Extended-Release Tablets 30 mg
Class IIFailed Impurities/Degradation Specification
Dr. Reddy's Laboratories, Inc. · Oct 22, 2024
Morphine Sulfate Extended-Release Tablets 15 mg
Class IIFailed Impurities/Degradation Specification
Dr. Reddy's Laboratories, Inc. · Oct 22, 2024
Chlorpheniramine Maleate 4 mg tablets
Class IISuperpotent Drug: Stability failure for assay at 6 months test time-point.
BLI International, Inc. · Oct 21, 2024
Sunitinib Malate Capsules
Class IILabeling: Label Mix-Up
AvKARE · Oct 18, 2024
Sunitinib Malate Capsules
Class IILabeling: Label Mix-Up
AvKARE · Oct 18, 2024
Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution
Class IISubpotent Drug
Keystone Industries · Oct 17, 2024
OneLAX Docusate Sodium Liquid 50 mg/5 mL) Stool Softener Laxative
Class IICGMP Deviations
Akron Pharma, Inc. · Oct 15, 2024
Triamcinolone Acetonide Cream USP
Class IIISubpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
Padagis US LLC · Oct 11, 2024
Cinacalcet Tablets 30 mg
Class IICGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
ACCORD HEALTHCARE, INC. · Oct 10, 2024
Cinacalcet Tablets
Class IICGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
ACCORD HEALTHCARE, INC. · Oct 10, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc · Oct 10, 2024
Showing 40 of 1,903 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.