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
Asmanex Twisthaler
Class IIIDefective Container
Organon Llc · May 28, 2024
Docetaxel Injection
Class IPresence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Sagent Pharmaceuticals · May 28, 2024
Little Remedies Gas Relief Drops (Simethicone/Antigas)
Class IIcGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Denison Pharmaceuticals, LLC · May 28, 2024
Asmanex Twisthaler
Class IIIDefective Container
Organon Llc · May 28, 2024
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
Docetaxel Injection
Class IPresence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Sagent Pharmaceuticals · 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, BUFF, Broad S…
Class IMicrobial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
SYNCHRONICITY SPA INC, DBA SUNTE · May 24, 2024
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shad…
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
Eptifibatide injection 20mg/10mL (2mg/mL)
Class IIIFailed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Eugia US LLC · May 22, 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
Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension
Class IIILabeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.
GlaxoSmithKline LLC · May 17, 2024
Estradiol Transdermal System
Class IIIFailed Impurities/Degradation Specifications.
Zydus Pharmaceuticals (USA) Inc · May 16, 2024
Pregabalin Capsules 50mg
Class IIIPresence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
Rising Pharma Holding, Inc. · May 16, 2024
Estradiol Transdermal System
Class IIIFailed Impurities/Degradation Specifications.
Zydus Pharmaceuticals (USA) Inc · May 16, 2024
EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40…
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 mg/mL Preservative-Free 1mL Single-…
Class IILack of Assurance of Sterility
Imprimis NJOF, LLC · May 14, 2024
Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5m…
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 mg/mL Preservative-Free 1mL Single-…
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 Intraocu…
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 Intraocula…
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
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.