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
Isotretinoin Capsules
Class IISuperpotent Drug: The 3-month stability result for assay was found to be above specification limit
Teva Pharmaceuticals USA, Inc · Mar 28, 2024
Atovaquone Oral Suspension USP
Class IMicrobial contamination of a non-sterile product: potential Bacillus cereus contamination.
AvKARE · Mar 28, 2024
NEXLIZET (bempedoic acid and ezetimibe) tablets
Class IIIFailed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Esperion · Mar 27, 2024
Lansoprazole Delayed-Release Capsules USP
Class IICGMP Deviations
NATCO Pharma Limited · Mar 27, 2024
Diltiazem Hydrochloride Extended-Release Capsules
Class IIFailed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Glenmark Pharmaceuticals Inc., USA · Mar 26, 2024
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP
Class IIShort fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Cipla USA, Inc. · Mar 26, 2024
Digoxin Tablets
Class IIIFailed Impurities/Degradation Specifications
Novitium Pharma LLC · Mar 25, 2024
Methylergonovine Maleate Tablets
Class IIFailed Dissolution Specifications
Amneal Pharmaceuticals of New York, LLC · Mar 25, 2024
Aruba Aloe Hand Sanitizer Gel
Class IChemical Contamination: Product manufactured with ethanol API that contains methanol
Aruba Aloe Balm N.V. · Mar 23, 2024
Alcoholada Gel
Class IChemical Contamination: Product manufactured with ethanol API that contains methanol
Aruba Aloe Balm N.V. · Mar 23, 2024
Lactated Ringer's Injection USP
Class IILack of assurance of sterility: bags have the potential to leak..
B. Braun Medical Inc · Mar 22, 2024
fentaNYL Citrate 2
Class IILack of Assurance of Sterility: leaking bags
IntegraDose Compounding Services LLC · Mar 22, 2024
Vancomycin Hydrochloride for Oral Solution
Class ISuperpotent Drug: Due to overfilling of drug powder
Amneal Pharmaceuticals of New York, LLC · Mar 21, 2024
Rifampin Capsules USP
Class IISubpotent Drug
Lupin Pharmaceuticals Inc. · Mar 21, 2024
VCF Vaginal Contraceptive Film (nonoxynol-9
Class IIcGMP Diviations
Apothecus Pharmaceutical Corp. · Mar 21, 2024
GoHARD 25000
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale Inc. · Mar 19, 2024
libigrow RED DRAGON+
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale Inc. · Mar 19, 2024
The GOAT SUBLINGUAL STRIP
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale Inc. · Mar 19, 2024
SILVERBACK XXX POWER MALE ENHANCEMENT
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale Inc. · Mar 19, 2024
HONEY MANUKA BUNNY LOVE
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale Inc. · Mar 19, 2024
ALPHASTRIP MALE PERFORMANCE ENHANCER
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale Inc. · Mar 19, 2024
Samurai-X Honey 6800
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale Inc. · Mar 19, 2024
Spanish Fly 22K capsules
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale Inc. · Mar 19, 2024
Pink Pussycat Honey
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale Inc. · Mar 19, 2024
Flower Power
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale Inc. · Mar 19, 2024
Weiner Boner Honey
Class IMarketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Pyramids Wholesale Inc. · Mar 19, 2024
Infumorph (Preservative-free Morphine Sulfate Sterile Solution)
Class IIThe filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Hikma Pharmaceuticals USA Inc. · Mar 12, 2024
Sterile Diluent
Class IICGMP Deviations
Eli Lilly & Company · Mar 12, 2024
Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP
Class IIFailed Dissolution Specifications
Teva Pharmaceuticals USA, Inc · Mar 7, 2024
Potassium Chloride for Injection Concentrate USP
Class IILack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
B. Braun Medical Inc · Mar 6, 2024
Betimol (timolol ophthalmic solution) 0.5%
Class IILack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Thea Pharma, Inc. · Mar 5, 2024
Digoxin Tablets
Class IIICross Contamination with Other Products:(mycophenolate mofetil).
Novitium Pharma LLC · Mar 4, 2024
Febuxostat Tablets 40mg
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Mar 4, 2024
Febuxostat Tablets 80mg
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Mar 4, 2024
Treprostinil Injection
Class IPresence of Particulate Matter.
Par Sterile Products LLC · Mar 4, 2024
S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or…
Class IIFailed Stability Specifications
Specialty Process Labs LLC · Mar 1, 2024
S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging…
Class IIFailed Stability Specifications
Specialty Process Labs LLC · Mar 1, 2024
hyalogic For Dry Eyes
Class IILack of Assurance of Sterility
Optikem International, Inc. · Feb 29, 2024
TRP Natural Eyes Dryness Relief
Class IILack of Assurance of Sterility
Optikem International, Inc. · Feb 29, 2024
FentaNYL citrate
Class IILack of Assurance of Sterility: Firm did not perform process validation.
SSM Health Care St. Louis DBA SSM St. Clare Health Center · Feb 29, 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.