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
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
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
Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 2025
Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 2025
Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 2025
Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 2025
Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 2025
Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 2025
Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 2025
Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 2025
Semaglutide + Cyanocobalamin injection solution
Class IILack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 2025
Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Breckenridge Pharmaceutical, Inc. · Jul 15, 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.
Nostrum Laboratories, Inc. · Jul 11, 2025
Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-On…
Class IICGMP Deviations
A.P. Deauville, LLC · Jul 10, 2025
Bicillin L-A (penicillin G benzathine injectable suspension)
Class IICGMP Deviations; particulates identified during visual inspection
Pfizer Inc. · Jul 10, 2025
Beauty & Skincare Power Stick original nourishing invisible protection roll-on…
Class IICGMP Deviations
A.P. Deauville, LLC · Jul 10, 2025
Bicillin L-A (penicllin G benzathine injectable suspension)
Class IICGMP Deviations; particulates identified during visual inspection
Pfizer Inc. · Jul 10, 2025
Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fre…
Class IICGMP Deviations
A.P. Deauville, LLC · Jul 10, 2025
Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy
Class IISubpotent Drug
Boothwyn Pharmacy LLC · Jul 9, 2025
Rizatriptan Benzoate Tablets
Class IICGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Ascend Laboratories, LLC · Jul 9, 2025
Cinacalcet Tablets 90 mg
Class IIFailed Dissolution Specifications.
Strides Pharma, Inc. · Jul 9, 2025
Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy
Class IISubpotent Drug
Boothwyn Pharmacy LLC · Jul 9, 2025
Epinephrine Lidocaine HCL
Class IISub-Potent Drug: Subpotent assay results during stability testing.
Imprimis NJOF, LLC · Jul 9, 2025
Showing 40 of 1,472 Class II recalls (1,769 tracked in total).
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.