DrugMay 27, 2026
Primidone Tablets, USP, 250 mg, 100 Tablets recall — FDA D-0536-2026
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class IIIFDA: OngoingAmerisource Health Services LLC
754drug recall records
53FDA Class I records
8firms with 5+ records
Zydus Pharmaceuticals…31 records
Database records
Records — page 6
754 detailed records are currently available in this category.
DrugMay 27, 2026
Safecor Health Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid recall — FDA D-0549-2026
Presence of a Foreign Substance; black particles observed in liquid
Class IIFDA: OngoingSafecor Health, LLC
DrugMay 20, 2026
Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile recall — FDA D-0525-2026
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
Class IIFDA: OngoingOasis Medical, Inc.
DrugMay 13, 2026
Central Admixture Pharmacy Services, Inc (CAPS) TPN bag (patient specific), Rx# recall — FDA D-0524-2026
Incorrect Product Formulation: product did not contain insulin as listed in the label.
Class IIFDA: OngoingCentral Admixture Pharmacy Services, Inc (CAPS) Los…
DrugMay 13, 2026
PURPREP BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol recall — FDA D-0518-2026
Lack of assurance of Sterility: potential product contamination
Class IIFDA: OngoingCareFusion 213, LLC
DrugMay 13, 2026
Duloxetine Delayed-Release Capsules, 30 mg recall — FDA D-0514-2026
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Class IIFDA: OngoingAjanta Pharma Ltd.
DrugMay 13, 2026
Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle recall — FDA D-0520-2026
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Class IIFDA: OngoingJB Chemicals and Pharmaceuticals Ltd
DrugMay 13, 2026
Duloxetine Delayed-Release Capsules, 20 mg recall — FDA D-0516-2026
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Class IIFDA: OngoingAjanta Pharma Ltd.
DrugMay 13, 2026
Duloxetine Delayed-Release Capsules USP, 60mg recall — FDA D-0522-2026
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class IIFDA: OngoingBreckenridge Pharmaceutical, Inc.
DrugMay 13, 2026
Fresenius Medical Care Holdings DELFLEX, Dextrose Peritoneal Dialysis Solution with attached recall — FDA D-0513-2026
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.
DrugMay 13, 2026
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In recall — FDA D-0519-2026
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class IIFDA: OngoingTeva Pharmaceuticals USA, Inc
DrugMay 13, 2026
Fresenius Medical Care Holdings DELFLEX, Dextrose Peritoneal Dialysis Solution with attached recall — FDA D-0512-2026
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Class IIFDA: OngoingFresenius Medical Care Holdings, Inc.
DrugMay 13, 2026
Duloxetine Delayed-Release Capsules, 60 mg recall — FDA D-0515-2026
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Class IIFDA: OngoingAjanta Pharma Ltd.
DrugMay 6, 2026
Thea Pharma Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz recall — FDA D-0501-2026
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Class IIFDA: OngoingThea Pharma, Inc.
DrugMay 6, 2026
IVIZIA DRY EYE iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made recall — FDA D-0500-2026
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Class IIFDA: OngoingThea Pharma, Inc.
DrugMay 6, 2026
GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz) recall — FDA D-0492-2026
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Class IIFDA: OngoingAlcon Research LLC
DrugMay 6, 2026
Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL recall — FDA D-0526-2026
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Class IIFDA: OngoingHikma Pharmaceuticals USA INC
DrugMay 6, 2026
SYSTANE recall — FDA D-0491-2026
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Class IIFDA: OngoingAlcon Research LLC
DrugApr 29, 2026
OMEGA-3-ACID ETHYL ESTERS Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules recall — FDA D-0493-2026
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Class IIFDA: OngoingThe Harvard Drug Group LLC
DrugApr 29, 2026
MONSELS SOLUTION Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles recall — FDA D-0490-2026
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that…
Class IIIFDA: OngoingPremier Dental Products Co
DrugApr 29, 2026
Claravis recall — FDA D-0521-2026
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Class IIFDA: OngoingTeva Pharmaceuticals USA, Inc
DrugApr 29, 2026
Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle recall — FDA D-0484-2026
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Class IIFDA: OngoingHetero Labs Limited (Unit V)
DrugApr 22, 2026
FLUOCINONIDE recall — FDA D-0476-2026
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES INC
DrugApr 22, 2026
MGC HEALTH recall — FDA D-0462-2026
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on…
Class IIFDA: OngoingXiamen Kang Zhongyuan Biotechnology Co., Ltd.
How to use this drug recall index
A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.