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
Cephalexin for Oral Suspension
Class IIILabeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Bryant Ranch Prepack, Inc. · May 10, 2024
Rizatriptan Benzoate Tablets USP
Class IICGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Glenmark Pharmaceuticals Inc., USA · May 10, 2024
Cephalexin for Oral Suspension
Class IIILabeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'
Bryant Ranch Prepack, Inc. · May 10, 2024
Cephalexin for Oral Suspension
Class IIILabeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g
Bryant Ranch Prepack, Inc. · May 10, 2024
Cefdinir for Oral Suspension USP
Class IIDefective container: lack of seal integrity.
Lupin Pharmaceuticals Inc. · May 8, 2024
Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable…
Class IIFailed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
PACIRA PHARMACEUTICALS INC · May 7, 2024
Losartan Potassium and Hydrochlorothiazide Tablets
Class IIPresence of foreign substance: plastic-like substance.
MACLEODS PHARMA USA, INC · May 7, 2024
Metoprolol Tartrate Tablets USP
Class IIPresence of Foreign Substance: metal in tablet
Rubicon Research Private Limited · May 6, 2024
TraMADol HCl 50 mg Tablet
Class IIPresence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
RemedyRepack Inc. · May 2, 2024
CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Flavo…
Class IIMicrobial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Pharma Nobis LLC · May 1, 2024
Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free
Class IIMicrobial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Pharma Nobis LLC · May 1, 2024
Sirolimus Tablets 1mg Tablets 100-count bottle
Class IIIFailed Impurities/Degradation Specifications
Dr. Reddy's Laboratories, Inc. · May 1, 2024
Cardura XL (doxazosin) extended release tablets 4mg
Class IIFailed Impurities/Degradation Specifications
Viatris Inc · Apr 30, 2024
Cardura XL (doxazosin) extended release tablets 8mg
Class IIFailed Impurities/Degradation Specifications
Viatris Inc · Apr 30, 2024
Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection
Class IIILabeling: Wrong Barcode
Hikma Injectables USA Inc · Apr 30, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc · Apr 29, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc · Apr 29, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc · Apr 29, 2024
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free
Class ILabeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Hikma Injectables USA Inc · Apr 29, 2024
traMADol Hydrochloride Tablets
Class IIPresence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Rubicon Research Private Limited · Apr 26, 2024
Valacyclovir Tablets USP
Class IIIFailed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Viatris Inc · Apr 25, 2024
MethylPREDNISolone Acetate Injectable Suspension
Class IIPresence of Particulate Matter: Potential for black particulates in the drug product.
Sagent Pharmaceuticals · Apr 25, 2024
Timolol Maleate Ophthalmic Solution
Class IIDefective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
FDC Limited · Apr 25, 2024
Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted)
Class IIPresence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Lupin Pharmaceuticals Inc. · Apr 24, 2024
Progesterone 200 mg
Class IIPresence of Foreign Substance; Broken metal piece found embedded in tablet.
Coast Quality Pharmacy, LLC dba Anazao Health · Apr 24, 2024
Sodium Sulfacetamide 10%
Class IIISubpotent drug
Acella Pharmaceuticals, LLC · Apr 24, 2024
Clorazepate Dipotassium Tablets
Class IIDiscoloration: Dotted and yellow spots on tablets
Aurobindo Pharma USA Inc. · Apr 24, 2024
Clorazepate Dipotassium Tablets
Class IIDiscoloration: Dotted and yellow spots on tablets
Aurobindo Pharma USA Inc. · Apr 24, 2024
Haloperidol decanoate Injection 50mg/mL
Class IIPresence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
SOMERSET THERAPEUTICS LLC · Apr 24, 2024
Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted)
Class IIPresence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Lupin Pharmaceuticals Inc. · Apr 24, 2024
minolira (minocycline hydrochloride) extended-release tablets
Class IICGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
EPI Health, LLC · Apr 23, 2024
EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose…
Class IILack of Assurance of Sterility: Complaints of syringe breakage
Regeneron Pharmaceuticals Inc · Apr 23, 2024
Cloderm (clocortolone pivalate) Cream
Class IICGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
EPI Health, LLC · Apr 23, 2024
minolira (minocycline hydrochloride) extended-release tablets
Class IICGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
EPI Health, LLC · Apr 23, 2024
Schwinnng Herbal Dietary Supplement Capsules
Class IMarketed Without An Approved NDA/ANDA
Stop Clopez Corp · Apr 22, 2024
Xelpros (latanoprost ophthalmic emulsion) 0.005%
Class IIIFailed Release Testing: Out of specification for particulate matter test.
SUN PHARMACEUTICAL INDUSTRIES INC · Apr 22, 2024
Tirzepatide 10 mg/0.5 mL Sterile Solution
Class ILabeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Revive Rx LLC dba Revive Rx Pharmacy · Apr 20, 2024
FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein),…
Class IIFailed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Nomax Inc · Apr 19, 2024
GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx Onl…
Class IIFailed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Nomax Inc · Apr 19, 2024
FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per c…
Class IIFailed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Nomax Inc · Apr 19, 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.