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
Simethicone 20 mg per 0.3 mL Oral Syringe
Class IIDefective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Safecor Health, LLC · Feb 17, 2025
Morphine Sulfate 5 mg per 0.25 mL Oral Syringe
Class IIDefective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Safecor Health, LLC · Feb 17, 2025
Medline Alcohol Prep Pads
Class IISubpotent Drug
MEDLINE INDUSTRIES, LP - Northfield · Feb 17, 2025
Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe
Class IIDefective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Safecor Health, LLC · Feb 17, 2025
Lorazepam 0.5 mg per 0.25 mL Oral Syringe
Class IIDefective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Safecor Health, LLC · Feb 17, 2025
CURAD Alcohol Prep Pads
Class IISubpotent Drug
MEDLINE INDUSTRIES, LP - Northfield · Feb 17, 2025
Ergocalciferol
Class IIDefective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Safecor Health, LLC · Feb 17, 2025
BD ChloraPrep Clear 1mL Applicators
Class INon-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
CareFusion 213, LLC · Feb 14, 2025
Nelarabine Injection
Class IIFailed Impurities/Degradation Specifications
Zydus Pharmaceuticals (USA) Inc · Feb 13, 2025
Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%
Class IIChemical Contamination
Johnson, S C and Son, Inc · Feb 13, 2025
POTASSIUM CHLORIDE Inj.
Class ILabeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
ICU Medical, Inc. · Feb 13, 2025
Nelarabine Injection
Class IIFailed Impurities/Degradation Specifications
Zydus Pharmaceuticals (USA) Inc · Feb 13, 2025
POTASSIUM CHLORIDE Inj.
Class ILabeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
ICU Medical, Inc. · Feb 13, 2025
Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide…
Class IIChemical Contamination
Johnson, S C and Son, Inc · Feb 13, 2025
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: The product packed in white poly bag…
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…
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…
Class IICGMP Deviations
Aspen Biopharma Labs Pvt., Ltd. · Feb 7, 2025
Chlorambucil Container Description: The product packed in double self-seal…
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
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.