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
Just Right 5000
Class IIILABELING: LABEL MIX-UP.
Elevate Oral Care · Aug 20, 2024
Varithena (polidocanol injectable foam) Administration Pack
Class IIIDefective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).
Biocompatibles UK, Ltd. · Aug 15, 2024
Hydrocortisone 1% & Acetic Acid 2% Otic Solution
Class IIIFailed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Taro Pharmaceuticals U.S.A., Inc. · Aug 7, 2024
Methotrexate Tablets
Class IIIPresence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Amneal Pharmaceuticals, LLC · Aug 1, 2024
Acetaminophen
Class IIILabel mix-up: Carton incorrectly labeled.
Granules Consumer Health Inc. · Jul 18, 2024
Micafungin for injection
Class IIICross contamination with other products
Zydus Pharmaceuticals (USA) Inc · Jul 2, 2024
PEG-3350, Sodium Sulfate, Chloride, Potassium Ascorbate, and Ascorbic Acid for…
Class IIIDefective container: potential for non-sealed pouches which can lead to product leakage.
Novel Laboratories, Inc. d.b.a Lupin Somerset · Jul 2, 2024
Micafungin for injection
Class IIICross contamination with other products
Zydus Pharmaceuticals (USA) Inc · Jul 2, 2024
Verapamil Hydrochloride Injection
Class IIICross contamination with other products.
Zydus Pharmaceuticals (USA) Inc · Jul 2, 2024
Verapamil Hydrochloride Injection
Class IIICross contamination with other products.
Zydus Pharmaceuticals (USA) Inc · Jul 2, 2024
Sevelamer Carbonate for Oral Suspension 0.8g packets
Class IIILabeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Dr. Reddy's Laboratories, Inc. · Jun 26, 2024
Hemp Bombs CBD Pain Freeze (menthol 4%)
Class IIISubpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
GLOBAL WIDGET LLC · Jun 25, 2024
Hemp Bombs CBD Pain Freeze (menthol 4%)
Class IIISubpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
GLOBAL WIDGET LLC · Jun 25, 2024
Nature's Script CBD Cryotherapy Pain Relief Roll on (menthol 4%) 200mg
Class IIISubpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
GLOBAL WIDGET LLC · Jun 25, 2024
Hemp Bombs CBD Pain Freeze (menthol 4%)
Class IIISubpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
GLOBAL WIDGET LLC · Jun 25, 2024
SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution
Class IIISub-potent Drug
Neilmed Pharmaceuticals Inc · Jun 24, 2024
Diflorasone Diacetate Ointment
Class IIIFailed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Rising Pharma Holding, Inc. · Jun 24, 2024
Dodex Injectable (Cyanocobalamin Injection) USP
Class IIISubpotent drug: out of specification results
Accord Healthcare, Inc. · Jun 18, 2024
Eszopiclone Tablets
Class IIIFailed Impurities/Degradation Specifications: Related Substances
Dr. Reddy's Laboratories, Inc. · Jun 4, 2024
Complete 30C/200C Homeopathic Kit
Class IIILabeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferrum Metallicum 200C.
Washington Homeopathic Products, Inc. · May 31, 2024
Asmanex Twisthaler
Class IIIDefective Container
Organon Llc · May 28, 2024
Asmanex Twisthaler
Class IIIDefective Container
Organon Llc · May 28, 2024
Asmanex Twisthaler
Class IIIDefective Container
Organon Llc · May 28, 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
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
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
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
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
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
Sirolimus Tablets 1mg 100-count bottle
Class IIIFailed Impurities/Degradation Specifications
Dr. Reddy's Laboratories, Inc. · May 1, 2024
Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection
Class IIILabeling: Wrong Barcode
Hikma Injectables USA Inc · Apr 30, 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
Sodium Sulfacetamide 10%
Class IIISubpotent drug
Acella Pharmaceuticals, LLC · Apr 24, 2024
Xelpros (latanoprost ophthalmic emulsion) 0.005%
Class IIIFailed Release Testing: Out of specification for particulate matter test.
SUN PHARMACEUTICAL INDUSTRIES INC · Apr 22, 2024
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 Preservative-Free
Class IIIOut of specification for assay
Imprimis NJOF, LLC · Apr 10, 2024
Abilify (aripiprazole)
Class IIICross Contamination with Other Products
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. · Apr 9, 2024
Showing 40 of 176 Class III 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.