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
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 Repa…
Class IIFailed Stability Specifications
Specialty Process Labs LLC · Mar 1, 2024
S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Us…
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
TRP Natural Eyes Pink Eye Relief
Class IILack of Assurance of Sterility
Optikem International, Inc. · Feb 29, 2024
TRP Blur Relief
Class IILack of Assurance of Sterility
Optikem International, Inc. · Feb 29, 2024
TRP Eye Twitching Relief
Class IILack of Assurance of Sterility
Optikem International, Inc. · Feb 29, 2024
TRP Natural Eyes Red Eye Relief
Class IILack of Assurance of Sterility
Optikem International, Inc. · Feb 29, 2024
TRP Eye strain Relief
Class IILack of Assurance of Sterility
Optikem International, Inc. · Feb 29, 2024
TRP Natural Eyes Aging Eye Relief
Class IILack of Assurance of Sterility
Optikem International, Inc. · Feb 29, 2024
TRP Natural Eyes Allergy Eyes Relief
Class IILack of Assurance of Sterility
Optikem International, Inc. · Feb 29, 2024
TRP Natural Eyes Floaters Relief
Class IILack of Assurance of Sterility
Optikem International, Inc. · Feb 29, 2024
Phenylephrine HCl
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
Tobramycin for Injection
Class IIFailed Stability Specification: Water determination was found not complying with specification.
Eugia US LLC · Feb 22, 2024
Moxifloxacin PF
Class IIPresence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Denver Solutions, LLC DBA Leiters Health · Feb 20, 2024
Lidocaine HCL 1% (10mg/mL)
Class IIPresence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Denver Solutions, LLC DBA Leiters Health · Feb 20, 2024
Clindamycin Phosphate Topical Solution USP
Class IIIDefective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
Contract Pharmaceuticals Limited Canada · Feb 20, 2024
Methylprednisolone acetate Injectable Suspension
Class IIFailed Dissolution Specifications
Eugia US LLC · Feb 20, 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.