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
Enoxaparin Sodium Injection
Class IICorrect Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Cardinal Health Inc. · Aug 5, 2025
Sensodyne PRONAMEL (Potassium nitrate 5%
Class IIILabeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
Haleon US Holdings LLC · Aug 5, 2025
Vial Label: 8.4% Sodium Bicarbonate Injection
Class IILack of Assurance of Sterility.
PFIZER INC · Aug 4, 2025
Vial Label: Epinephrine Injection
Class IILack of Assurance of Sterility.
PFIZER INC · Aug 4, 2025
Lactated Ringer's Injection USP
Class IILack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
B BRAUN MEDICAL INC · Aug 4, 2025
0.9% Sodium Chloride Injection USP
Class IILack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
B BRAUN MEDICAL INC · Aug 4, 2025
Ultra Burn for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Semaglutide with B12 for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Xolair (omalizumab injection)
Class IICGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Cardinal Health Inc. · Jul 30, 2025
Sterile Saline Reconstitution Solution for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
B6 (Pyridoxine HCl) for Injections
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Sermorelin Lyophilized powder for reconstitution
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
BPC-157/Thymosin Beta-4 for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Low Solubility Peptide Reconstitution Solution for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
L-Arginine HCl for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Thymosin Beta-4 (TB4) for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Ascorbic Acid (Vitamin C) for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Zinc Chloride for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Xolair (omalizumab injection)
Class IICGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Cardinal Health Inc. · Jul 30, 2025
4.2% Sodium Bicarbonate Injection
Class IIFailed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Exela Pharma Sciences LLC · Jul 30, 2025
L-Glutamine for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Lipo MIC +B12 Methylcobalamin for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
CoQ10 for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
NAD+ (Nicotinamide adenine dinucleotide) for Injection
Class IMicrobial Contamination of Sterile Products: elevated endotoxin levels
GenoGenix LLC · Jul 30, 2025
Zinc Sulfate for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Epithalon for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Pentosan for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
B-Complex for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
GAC for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
B12 Methylcobalamin for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Ascorbic Acid (Vitamin C) for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Elite Stack Reconstitution Solution for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Elite Stack MSC Exosome Reconstitution Solution for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
pH Buffered Reconstitution Solution for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Semaglutide for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Proline for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
B5 Dexpanthenol for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Alpha Lipoic Acid for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Lipo MIC + L-Carnitine for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
EDTA for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 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.