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
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda…
Class IICGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Cardinal Health Inc. · Jul 30, 2025
B12 Hydroxocobalamin for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Oxytocin for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Glutathione Preserved for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Glutathione Magnesium for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Retatrutide for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
BPC-157 for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Vitamin D3 for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Tri-Immune for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
L-Arginine for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Taurine for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Bacteriostatic Water for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations,…
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Tesamorelin for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Amino Blend for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Calcium Chloride for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Biotin for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Lysine for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Methylene Blue for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
NAD+ (Nicotinamide adenine dinucleotide)
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
N-Acetyl-L-Cysteine for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
L-Carnitine for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Cerebrolysin for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Magnesium Chloride for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
GHK-Cu (Copper Peptide) for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Glycine for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Reconstitution XO Solution for Injection
Class IILack of Assurance of Sterility
GenoGenix LLC · Jul 30, 2025
Sucralfate Tablets
Class IICGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Amerisource Health Services LLC · Jul 29, 2025
Levoxyl (levothyroxine sodium tablets
Class IISubpotent drug
Pfizer · Jul 29, 2025
Doxepin Hydrochloride Capsules
Class IICGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Alembic Pharmaceuticals Limited · Jul 25, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Breckenridge Pharmaceutical, Inc. · Jul 25, 2025
Albuterol Sulfate
Class IIIFailed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Cipla USA, Inc. · Jul 24, 2025
BZK Antiseptic Towelette
Class IILack of Assurance of Sterility.
Taizhou Kangping Medical Science And Technology Co., Ltd. · Jul 22, 2025
Lorazepam Injection
Class IIFailed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Hikma Pharmaceuticals USA Inc. · Jul 22, 2025
Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%)
Class IIcGMP Deviations
YANGZHOU YULOU PAPER PRODUCTS CO., LTD · Jul 21, 2025
Belsomra (suvorexant) tablets
Class IIFailed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.
Merck & Co. Inc · Jul 21, 2025
Amlodipine and Olmesartan Medoxomil Tablets
Class IIFailed Dissolution Specifications: low dissolution results
Ascend Laboratories, LLC · Jul 21, 2025
Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 2025
Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 2025
Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 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.