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
Petroleum Jelly
Class IILabeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile
Consumer Product Partners, LLC · May 28, 2024
Phenazopyridine HCl Tablets USP
Class IIProduct Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Winder Laboratories, LLC · May 28, 2024
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple…
Class IICGMP Deviations
SYNCHRONICITY SPA INC, DBA SUNTE · May 24, 2024
Zoledronic Acid Injection 5mg/100mL Sterile Solution
Class IILack of Assurance of Sterility: Leaking vials
Dr. Reddy's Laboratories, Inc. · May 23, 2024
Dexamethasone Sodium Phosphate injection USP
Class IIFailed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Eugia US LLC · May 23, 2024
OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets
Class IIMarketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
MexHealth LLC · May 22, 2024
Extra Strength Acetaminophen 500 MG Tablets
Class IIDiscoloration: Brownish tablets
Contract Pharmacal Corporation · May 20, 2024
Buprenorphine Hydrochloride Injection
Class IILack of Assurance of Sterility-The potential for incomplete crimp seals.
Pfizer Inc. · May 20, 2024
Labetalol Hydrochloride Injection
Class IILack of Assurance of Sterility-The potential for incomplete crimp seals.
Pfizer Inc. · May 20, 2024
Cathflo activase (ALTEPLASE)
Class IILack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Genentech, Inc. · May 20, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc · May 17, 2024
EYLEA, (aflibercept) Injection, For Intravitreal 2 mg (0.05mL of a 40mg/mL…
Class IILack of Assurance of Sterility: Complaints of syringe breakage
Regeneron Pharmaceuticals Inc · May 15, 2024
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
Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1%…
Class IILack of Assurance of Sterility
Imprimis NJOF, LLC · May 14, 2024
Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free
Class IILack of Assurance of Sterility
Imprimis NJOF, LLC · May 14, 2024
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
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
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
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
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
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
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
Showing 40 of 1,576 Class II recalls (1,895 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.