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
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 Preservative-Free 1mL Single-Use…
Class IILack of Assurance of Sterility
Imprimis NJOF, LLC · May 14, 2024
niCARdipine Hydrochloride Injection
Class IILack of Assurance of Sterility.
American Regent, Inc. · May 14, 2024
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for…
Class IILack of Assurance of Sterility
Imprimis NJOF, LLC · May 14, 2024
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for…
Class IILack of Assurance of Sterility
Imprimis NJOF, LLC · May 14, 2024
Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL
Class IILack of Assurance of Sterility
Imprimis NJOF, LLC · May 14, 2024
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension
Class IILack of Assurance of Sterility
Imprimis NJOF, LLC · May 14, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Golden State Medical Supply Inc. · May 13, 2024
Vasopressin Injection
Class IISubpotent product in addition to having out-of-specification results for impurities.
American Regent, Inc. · May 13, 2024
Rizatriptan Benzoate Orally Disintegrating Tablets
Class IICGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Glenmark Pharmaceuticals Inc., USA · May 13, 2024
Rizatriptan Benzoate Orally Disintegrating Tablets
Class IICGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Glenmark Pharmaceuticals Inc., USA · May 13, 2024
Cephalexin for Oral Suspension
Class IIILabeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'
Bryant Ranch Prepack, Inc. · May 10, 2024
Rizatriptan Benzoate Tablets USP
Class IICGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Glenmark Pharmaceuticals Inc., USA · May 10, 2024
Cephalexin for Oral Suspension
Class IIILabeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Bryant Ranch Prepack, Inc. · May 10, 2024
Duloxetine Delayed-Release Cap USP 30mg
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Preferred Pharmaceuticals, Inc. · May 10, 2024
Cephalexin for Oral Suspension
Class IIILabeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Bryant Ranch Prepack, Inc. · May 10, 2024
Rizatriptan Benzoate Tablets USP
Class IICGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Glenmark Pharmaceuticals Inc., USA · May 10, 2024
Cephalexin for Oral Suspension
Class IIILabeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'
Bryant Ranch Prepack, Inc. · May 10, 2024
Cephalexin for Oral Suspension
Class IIILabeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g
Bryant Ranch Prepack, Inc. · May 10, 2024
Cefdinir for Oral Suspension USP
Class IIDefective container: lack of seal integrity.
Lupin Pharmaceuticals Inc. · May 8, 2024
Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable…
Class IIFailed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
PACIRA PHARMACEUTICALS INC · May 7, 2024
Losartan Potassium and Hydrochlorothiazide Tablets
Class IIPresence of foreign substance: plastic-like substance.
MACLEODS PHARMA USA, INC · May 7, 2024
Metoprolol Tartrate Tablets USP
Class IIPresence of Foreign Substance: metal in tablet
Rubicon Research Private Limited · May 6, 2024
TraMADol HCl 50 mg Tablet
Class IIPresence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
RemedyRepack Inc. · May 2, 2024
CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry…
Class IIMicrobial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Pharma Nobis LLC · May 1, 2024
Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free
Class IIMicrobial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Pharma Nobis LLC · May 1, 2024
Sirolimus Tablets 1mg 100-count bottle
Class IIIFailed Impurities/Degradation Specifications
Dr. Reddy's Laboratories, Inc. · May 1, 2024
Cardura XL (doxazosin) extended release tablets 4mg
Class IIFailed Impurities/Degradation Specifications
Viatris Inc · Apr 30, 2024
Cardura XL (doxazosin) extended release tablets 8mg
Class IIFailed Impurities/Degradation Specifications
Viatris Inc · Apr 30, 2024
Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection
Class IIILabeling: Wrong Barcode
Hikma Injectables USA Inc · Apr 30, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc · Apr 29, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc · Apr 29, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc · Apr 29, 2024
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free
Class ILabeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Hikma Injectables USA Inc · Apr 29, 2024
traMADol Hydrochloride Tablets
Class IIPresence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Rubicon Research Private Limited · Apr 26, 2024
Valacyclovir Tablets USP
Class IIIFailed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Viatris Inc · Apr 25, 2024
MethylPREDNISolone Acetate Injectable Suspension
Class IIPresence of Particulate Matter: Potential for black particulates in the drug product.
Sagent Pharmaceuticals · Apr 25, 2024
Timolol Maleate Ophthalmic Solution
Class IIDefective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
FDC Limited · Apr 25, 2024
Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted)
Class IIPresence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Lupin Pharmaceuticals Inc. · Apr 24, 2024
Progesterone 200 mg
Class IIPresence of Foreign Substance; Broken metal piece found embedded in tablet.
Coast Quality Pharmacy, LLC dba Anazao Health · Apr 24, 2024
Sodium Sulfacetamide 10%
Class IIISubpotent drug
Acella Pharmaceuticals, LLC · Apr 24, 2024
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.