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
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
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
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
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
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 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
Methylprednisolone acetate Injectable Suspension
Class IIFailed Dissolution Specifications
Eugia US LLC · Feb 20, 2024
Nicardipine Hydrochloride Injection (2.5mg/mL)
Class IIFailed Impurities/Degradation Specifications: Out of specification for organic impurities
Eugia US LLC · Feb 20, 2024
Moxifloxacin 5mg/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
Nicardipine Hydrochloride Injection
Class IIFailed Impurities/Degradation Specifications: Out of specification for organic impurities
Eugia US LLC · Feb 20, 2024
7 Eleven FOR GAS ISLAND USE ONLY
Class IICGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Seatex LLC · Feb 19, 2024
PROBLEND Antibacterial Foaming Silk All-In-One Hand Sanitizer & Cleanser
Class IICGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Seatex LLC · Feb 19, 2024
7 Eleven Hand Sanitizer Gel
Class IICGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Seatex LLC · Feb 19, 2024
PROBLEND Hand Sanitizer
Class IICGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Seatex LLC · Feb 19, 2024
PROBLEND E3 Foaming Hand Sanitizer
Class IICGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Seatex LLC · Feb 19, 2024
Broncochem Cold & Tea (acetaminophen
Class IIStability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Global Corporation · Feb 16, 2024
Broncochem Cold & Flu Syrup Kids (acetaminophen
Class IIStability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Global Corporation · Feb 16, 2024
Fluticasone Propionate Nasal Spray USP
Class IICGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Golden State Medical Supply Inc. · Feb 14, 2024
Oseltamivir Phosphate for Oral Suspension 6mg/ml
Class IIFailed Impurities/Degradation Specifications: Out-of-specification test results.
Amneal Pharmaceuticals of New York, LLC · Feb 13, 2024
Clobazam Tablets 10mg
Class IICGMP Deviations: Out of specification for residual solvents.
Micro Labs Limited · Feb 12, 2024
Showing 40 of 1,576 Class II 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.