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
Iodo Blanco Iodides
Class IIDefective Container: broken or leaking bottles.
World Perfumes Inc. · Feb 13, 2025
ViaMed Alcohol Prep Pads
Class IILack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Wuxi Medical lnstrument Factory Co., Ltd. · Feb 12, 2025
Sodium Chloride Injection 9%
Class IILack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Nephron Sterile Compounding Center LLC · Feb 10, 2025
Voriconazole Container Description: voriconazole The product packed in white pol…
Class IICGMP Deviations
Aspen Biopharma Labs Pvt., Ltd. · Feb 7, 2025
Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
Class IICGMP Deviations
Aspen Biopharma Labs Pvt., Ltd. · Feb 7, 2025
Bimatoprost NDC# 82187-1001-1 Container description: The product packed in dou…
Class IICGMP Deviations
Aspen Biopharma Labs Pvt., Ltd. · Feb 7, 2025
Alprostadil Container Description: Amber color bottle
Class IICGMP Deviations
Aspen Biopharma Labs Pvt., Ltd. · Feb 7, 2025
Finasteride NDC# 82187-1003-1 Container Description: The product packed in whit…
Class IICGMP Deviations
Aspen Biopharma Labs Pvt., Ltd. · Feb 7, 2025
Chlorambucil Container Description: The product packed in double self-seal cover…
Class IICGMP Deviations
Aspen Biopharma Labs Pvt., Ltd. · Feb 7, 2025
Morphine Sulfate Extended-Release Tablets
Class IIFailed Dissolution Specifications
SUN PHARMACEUTICAL INDUSTRIES INC · Feb 6, 2025
Estradiol Gel
Class IIDefective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Padagis US LLC · Feb 6, 2025
Silodosin Capsules
Class IISubpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
AvKARE · Feb 4, 2025
Fentanyl Transdermal System CII
Class IDefective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Alvogen, Inc · Jan 31, 2025
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII
Class IILack of Assurance of Sterility
Fagron Compounding Services · Jan 31, 2025
CIPROFLOXACIN OPHTH SOLUTION
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
Direct Rx · Jan 31, 2025
Potassium Chloride Extended-Release Tablets
Class IIFailed Dissolution Specifications.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Jan 30, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Jan 29, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Jan 29, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Jan 29, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Jan 29, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Jan 29, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Jan 29, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Jan 29, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Jan 29, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Jan 29, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Jan 29, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Jan 29, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Jan 29, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Jan 29, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Jan 29, 2025
SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium ch…
Class IMicrobial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Ascent Consumer Products Inc. · Jan 28, 2025
SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg a…
Class IMicrobial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Ascent Consumer Products Inc. · Jan 28, 2025
SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 70…
Class IMicrobial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Ascent Consumer Products Inc. · Jan 28, 2025
HydrALAZINE Hydrochloride
Class IIFailed Impurities/Degradation Specifications
SKY PACKAGING · Jan 24, 2025
HydrALAZINE Hydrochloride
Class IIFailed Impurities/Degradation Specifications
SKY PACKAGING · Jan 24, 2025
Carvedilol 25 mg Tablet
Class IICGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
RemedyRepack Inc. · Jan 24, 2025
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 · Jan 23, 2025
Carvedilol Tablets
Class IICGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Jan 22, 2025
Carvedilol Tablets
Class IICGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Jan 22, 2025
Lorazepam Tablets
Class IIFailed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Jan 21, 2025
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.