Drug recalls
FDA enforcement reports from the last 12 months · Class I is the most serious. Type in the filter box to search, click a column to sort, or toggle whether bulk API / for-further-processing products are included.
ⓘ How this was built
Data sources
- openFDA drug enforcement reports (FDA)
Method
Rows are FDA's own enforcement records, ingested daily; classifications and dates are FDA's. Filtering and counting only — no modeling.
Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.
| I | Optiray 350 D-0773-2026 | Liebel-Flarsheim Company LLC | Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. | Jul 31, 2026 | Ongoing |
| I | — D-0744-2026 | Sunny Pharmtech Inc. | Presence of Particulate Matter; identified as stainless steel | Jul 17, 2026 | Ongoing |
| I | — D-0743-2026 | Sunny Pharmtech Inc. | Presence of Particulate Matter; identified as stainless steel | Jul 17, 2026 | Ongoing |
| I | — D-0772-2026 | Victory Medical Center Pharmacy | Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin. | Jul 1, 2026 | Ongoing |
| I | Cetirizine Hydrochloride D-0732-2026 | JB Chemicals and Pharmaceuticals Ltd | Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP… | Jun 24, 2026 | Ongoing |
| I | — D-0595-2026 | Haleon US Holdings LLC | Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process. | Jun 4, 2026 | Ongoing |
| I | — D-0620-2026 | BEEKEEPER'S NATURALS USA INC. | Microbial Contamination of Non-Sterile Products | Jun 1, 2026 | Ongoing |
| I | ChloraPrep One-Step D-0624-2026 | CareFusion 213, LLC | Non-Sterility: Due to presence of Aspergillus penicillioides. | May 28, 2026 | Ongoing |
| I | ChloraPrep One-Step D-0625-2026 | CareFusion 213, LLC | Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal… | May 28, 2026 | Ongoing |
| I | Doxorubicin Hydrochloride D-0580-2026 | SUN PHARMACEUTICAL INDUSTRIES INC | Presence of Particulate matter: Particulate matter identified as glass. | May 12, 2026 | Ongoing |
| I | Lactated Ringers D-0540-2026 | B BRAUN MEDICAL INC | Presence of Particulate Matter. | Apr 28, 2026 | Ongoing |
| I | — D-0553-2026 | Wisconsin Pharmacal Company | Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus. | Apr 24, 2026 | Ongoing |
| I | — D-0692-2026 | Blaine Labs Inc | Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp | Apr 8, 2026 | Ongoing |
| I | — D-0769-2026 | Buy-Herbal | Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine. | Mar 21, 2026 | Ongoing |
| I | Magnesium Sulfate D-0478-2026 | Amneal Pharmaceuticals, LLC | Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead. | Mar 18, 2026 | Ongoing |
| I | — D-0528-2026 | Cardinal Health 200, LLC | Non-Sterility: microbial contamination identified as Paenibacillus phoenicis | Mar 2, 2026 | Ongoing |
| I | Udenyca D-0353-2026 | McKesson | Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the … | Jan 16, 2026 | Ongoing |
| I | — D-0332-2026 | HANDELNINE GLOBAL LLC | CGMP Deviations: product found to contain lead. | Dec 22, 2025 | Ongoing |
| I | — D-0397-2026 | StuffbyNainax | Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil | Dec 15, 2025 | Ongoing |
| I | ReBoost D-0288-2026 | Medinatura New Mexico, inc. | Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter. | Dec 12, 2025 | Ongoing |
Source: FDA drug enforcement reports (openFDA) · showing 20 of 27 recalls