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
Little Moon Essentials
Class IICGMP deviations
Little Moon Essentials LLC · Jun 20, 2024
Little Moon Essentials
Class IICGMP deviations
Little Moon Essentials LLC · Jun 20, 2024
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXT…
Class IIThis product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Fresenius Medical Care Holdings, Inc. · Jun 18, 2024
Venlafaxine Hydrochloride
Class IIFailed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Jun 18, 2024
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose
Class IILack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Baxter Healthcare Corporation · Jun 17, 2024
Methylphenidate Hydrochloride
Class IIFailed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Trigen Laboratories · Jun 17, 2024
Zilretta (triamcinolone acetonide extended-release injectable suspension)
Class IIFailed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C
PACIRA PHARMACEUTICALS INC · Jun 12, 2024
Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone)
Class IIMicrobial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Brands International Corporation · Jun 10, 2024
Allopurinol Tablets
Class IIPresence of foreign substance.
Dr. Reddy's Laboratories, Inc. · Jun 7, 2024
STELLALIFE ADVANCED FORMULA Peppermint
Class IIMicrobial Contamination of Non-Sterile Products: presence of Terribacillus species organism
Homeocare Laboratories, Inc. · Jun 5, 2024
Amoxicillin and Clavulanate Potassium Tablets USP
Class IISubpotent Drug
Teva Pharmaceuticals USA, Inc · Jun 4, 2024
Phenazopyridine HCl
Class IIProduct Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
RemedyRepack Inc. · May 31, 2024
Potassium Chloride Extended-Release Capsules
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · May 30, 2024
Potassium Chloride Extended-Release Capsules
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · May 30, 2024
Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size)
Class IIFailed Content Uniformity Specifications
Lupin Pharmaceuticals Inc. · May 30, 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
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 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
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 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
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.