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
CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient
Class IILack of Assurance of Sterility
Brassica Pharma Pvt Ltd · Jan 30, 2024
Equate Lubricant Eye Ointment (Mineral Oil 42.5%
Class IILack of Assurance of Sterility
Brassica Pharma Pvt Ltd · Jan 30, 2024
Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regime…
Class IIIDiscoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Teva Pharmaceuticals USA, Inc · Jan 25, 2024
Pure Care Foaming Mint Hand Sanitizer 62%
Class IICGMP Deviations
Alpha Aromatics · Jan 25, 2024
Febuxostat Tablets
Class IICGMP Deviations
Amerisource Health Services LLC · Jan 25, 2024
Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35
Class IIIDiscoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Teva Pharmaceuticals USA, Inc · Jan 25, 2024
Norepinephrine Bitartrate in 5% Dextrose Injection
Class IIIncorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
Baxter Healthcare Corporation · Jan 23, 2024
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection
Class IISub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
IntegraDose Compounding Services LLC · Jan 22, 2024
Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic
Class IICGMP Deviations: Potential Glass and Silicone particulates in product
Bestco LLC · Jan 19, 2024
Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS
Class IICGMP Deviations
OMEZA LLC · Jan 19, 2024
Omeza Skin Protectant
Class IICGMP Deviations
OMEZA LLC · Jan 19, 2024
Equate Cherry Cough Drops
Class IICGMP Deviations: Potential Glass and Silicone particulates in product
Bestco LLC · Jan 19, 2024
Kroger Cherry Cough Drops
Class IICGMP Deviations: Potential Glass and Silicone particulates in product
Bestco LLC · Jan 19, 2024
Meijer Cherry Cough Drops
Class IICGMP Deviations: Potential Glass and Silicone particulates in product
Bestco LLC · Jan 19, 2024
CVS Health Cherry Cough Drops
Class IICGMP Deviations: Potential Glass and Silicone particulates in product
Bestco LLC · Jan 19, 2024
Fexofenadine Hydrochloride Tablets
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Zolpidem Tartrate Extended-Release Tablets
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 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 · Jan 18, 2024
Glimepiride Tablets
Class IIIMisprint on tablet
Dr. Reddy's Laboratories, Inc. · Jan 18, 2024
Febuxostat Tablets 80 mg
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Niacin Extended-Release Tablets
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Niacin Extended-Release Tablets
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Lurasidone Hydrochloride Tablets 120mg
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Cinacalcet Tablets 60mg
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Mesalamine Delayed-Release Tablets
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Glimepiride Tablets
Class IIIMisprint on tablet
Dr. Reddy's Laboratories, Inc. · Jan 18, 2024
Zolpidem Tartrate Extended-Release Tablets
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Lurasidone Hydrochloride Tablets 60mg
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 18, 2024
Adrenalin (epinephrine) Injection 1mg/mL
Class IILabeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Henry Schein Inc. and Glove Club HSI Gloves Inc. · Jan 17, 2024
Fosfomycin Tromethamine Granules for Oral Solution
Class IIFailed Impurities/Degradation Specification: Out of specification for organic impurities
Ascend Laboratories, LLC · Jan 16, 2024
OralProCare medicated lip treatment
Class IICGMP Deviations: products may not conform to the labeled specifications.
Den-Mat Holdings, LLC · Jan 16, 2024
Hydrogen Peroxide Oral Rinse
Class IICGMP Deviations: products may not conform to the labeled specifications.
Den-Mat Holdings, LLC · Jan 16, 2024
Phenoxybenzamine Hydrochloride Capsules
Class IIFailed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Amneal Pharmaceuticals of New York, LLC · Jan 15, 2024
Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride
Class IISubpotent Drug
IntegraDose Compounding Services LLC · Jan 12, 2024
Neptune's Fix
Class IMarketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Neptune Resources, LLC · Jan 12, 2024
Neptune's Fix
Class IMarketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Neptune Resources, LLC · Jan 12, 2024
Neptune's Fix
Class IMarketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Neptune Resources, LLC · Jan 12, 2024
Budesonide Extended-Release Tablets
Class IIFailed Dissolution Specifications
Golden State Medical Supply Inc. · Jan 12, 2024
Rifampin Capsules USP
Class IIFailed Impurities/Degradation Specification.
Amerisource Health Services LLC · Jan 11, 2024
Vasostrict (vasopressin in 5% Dextrose) Injection
Class IISuperpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Par Sterile Products LLC · Jan 11, 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.