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
NATURAL PAIN RELIEVING CREAM
Class IIOut of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
ARG Laboratories, Inc. · Apr 17, 2024
NATURAL PAIN RELIEVING CREAM
Class IIOut of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
ARG Laboratories, Inc. · Apr 17, 2024
NATURAL PAIN RELIEVING CREAM
Class IIOut of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
ARG Laboratories, Inc. · Apr 17, 2024
NATURAL PAIN RELIEVING CREAM
Class IIOut of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
ARG Laboratories, Inc. · Apr 17, 2024
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol…
Class IIOut of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
ARG Laboratories, Inc. · Apr 17, 2024
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol…
Class IIOut of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
ARG Laboratories, Inc. · Apr 17, 2024
Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars
Class IIcGMP Deviations
Dercher Enterprises, Inc., DBA Gordon Laboratories · Apr 12, 2024
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution…
Class IISubpotent Drug
Imprimis NJOF, LLC · Apr 10, 2024
Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.…
Class IICGMP Deviations
HONEYWELL INC · Mar 29, 2024
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
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
Methylergonovine Maleate Tablets
Class IIFailed Dissolution Specifications
Amneal Pharmaceuticals of New York, LLC · Mar 25, 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
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 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
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.