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
OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxati…
Class IICGMP Deviations
Akron Pharma, Inc. · Oct 15, 2024
Cinacalcet Tablets 30 mg
Class IICGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
ACCORD HEALTHCARE, INC. · Oct 10, 2024
Cinacalcet Tablets
Class IICGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
ACCORD HEALTHCARE, INC. · Oct 10, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc · Oct 10, 2024
Cinacalcet Tablets
Class IICGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
ACCORD HEALTHCARE, INC. · Oct 10, 2024
Cinacalcet Tablets
Class IICGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Dr. Reddy's Laboratories, Inc. · Oct 9, 2024
Cinacalcet Tablets
Class IICGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Dr. Reddy's Laboratories, Inc. · Oct 9, 2024
Cinacalcet Tablets
Class IICGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Dr. Reddy's Laboratories, Inc. · Oct 9, 2024
LICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. (3785.4 mL mL…
Class IICGMP violations.
Neogen Corporation · Oct 8, 2024
AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas
Class IIMarketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
C & A Naturistics · Oct 8, 2024
LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per…
Class IICGMP violations.
Neogen Corporation · Oct 8, 2024
Cisplatin Injection
Class IIFailed Impurities/Degradation Specifications.
ACCORD HEALTHCARE, INC. · Oct 1, 2024
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
Class IIcGMP violations
Fresenius Kabi Compounding, LLC · Sep 25, 2024
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
Class IICGMP violations
Fresenius Kabi Compounding, LLC · Sep 25, 2024
Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP
Class IIcGMP violations
Fresenius Kabi Compounding, LLC · Sep 25, 2024
Thiamine HCl 0.9% Sodium Chloride Injection USP
Class IIcGMP violations
Fresenius Kabi Compounding, LLC · Sep 25, 2024
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
Class IIcGMP violations
Fresenius Kabi Compounding, LLC · Sep 25, 2024
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP
Class IIcGMP violations
Fresenius Kabi Compounding, LLC · Sep 25, 2024
Oxytocin 0.9% Sodium Chloride Injection USP
Class IIcGMP violations
Fresenius Kabi Compounding, LLC · Sep 25, 2024
EPINEPHrine 0.9% Sodium Chloride Injection USP
Class IIcGMP violations
Fresenius Kabi Compounding, LLC · Sep 25, 2024
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
Class IIcGMP violations
Fresenius Kabi Compounding, LLC · Sep 25, 2024
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP
Class IIcGMP violations
Fresenius Kabi Compounding, LLC · Sep 25, 2024
Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray
Class IIDefective Delivery System: The dip tube is clogged causing the spray not to work.
Glenmark Pharmaceuticals Inc., USA · Sep 24, 2024
Dapsone Gel 7.5%
Class IICrystallization
VIONA PHARMACEUTICALS INC · Sep 24, 2024
Atorvastatin Calcium Tablets
Class IIPresence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Nivagen Pharmaceuticals Inc · Sep 24, 2024
Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injec…
Class IICGMP deviations
Advanced Accelerator Applications USA, Inc. · Sep 23, 2024
EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v)
Class IICGMP deviations
EnviroServe Chemicals Inc. · Sep 18, 2024
Refresh LACRI-LUBE
Class IILack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
AbbVie Inc. · Sep 16, 2024
Refresh P.M.
Class IILack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
AbbVie Inc. · Sep 16, 2024
Proparacaine Hydrochloride Ophthalmic Solution
Class IITemperature abuse: Products exposed to improper temperature above drug label specifications.
Mckesson Medical-Surgical Inc. Corporate Office · Sep 11, 2024
Hylenex recombinant (hyaluronidase) injection
Class IIcGMP Deviations: Temperature excursion
Mckesson Medical-Surgical Inc. Corporate Office · Sep 11, 2024
First Aid Antiseptic Ointment
Class IIIncorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.
Zhejiang Jingwei Pharmaceutical Co., Ltd. · Sep 11, 2024
Pyridoxine HCL (B6) Injection Solution
Class IILack of Assurance of Sterility
Empower Pharmacy · Sep 5, 2024
Vivier Sheer SPF 30 Mineral With Antioxidants (titanium dioxide 10% and zinc oxi…
Class IIMicrobial Contamination of Non-Sterile Product
Vivier Pharma, Inc. · Sep 3, 2024
Mycophenolic Acid Delayed-Release Tablets USP
Class IIFailed Dissolution Specifications
Ascend Laboratories, LLC · Sep 3, 2024
Mupirocin Ointment
Class IISubpotent Drug
Glenmark Pharmaceuticals Inc., USA · Aug 30, 2024
BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal)
Class IIMicrobial contamination of non-sterile Products -
PREQUEL SKIN · Aug 28, 2024
SEMAGLUTIDE 10mg/4mL (2.5mg/mL)
Class IILack of Assurance of Sterility
ProRx LLC · Aug 22, 2024
TIRZEPATIDE 20 mg/2mL (10/mg/mL)
Class IILack of Assurance of Sterility
ProRx LLC · Aug 22, 2024
TIRZEPATIDE 60 mg/3mL (20/mg/mL)
Class IILack of Assurance of Sterility
ProRx LLC · Aug 22, 2024
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.