Recalls, Market Withdrawals, & Safety Alerts
The list below provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products. Not all recalls have press releases or are posted on this page. See Additional information about recalls for a more complete listing.
The Recalls, Market Withdrawals & Safety Alerts are available on FDA’s website for three years before being archived. To search archived content, visit Search FDA Archive and input the name of the product and/or company name in the Search terms box as well as the year to get the most inclusive search results. To scroll through archived Recalls, Market Withdrawals & Safety Alerts content by year, see the Recall and Safety Alerts Archive.
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| Date | Brand Name(s) | Product Description | Product Type | Recall Reason Description | Company Name | Terminated Recall | Excerpt |
|---|---|---|---|---|---|---|---|
| Oma’s Pride | Canine Food | Animal & Veterinary, Foodborne Illness, Pet Food, Food & Beverages, Foodborne Illness, Pet Food | Contaminated with Salmonella | Miller Foods, Inc. | … after having contact with this product should contact their healthcare providers. Pets with Salmonella infections may be … manufacturing experience. Our operations are conducted in accordance with applicable FDA and USDA requirements and are … | ||
| BD | Intraosseous Vascular Access System Needle Sets | Medical Devices | Due to Reports of Difficulty Removing the Obturator | (Becton, Dickinson and Company) | … use of these lots and destroy all affected needle sets in accordance with their facility’s process. BD will issue … The company supports those on the frontlines of healthcare by developing transformative technologies, … of products annually that have a positive impact on global healthcare. By working in close collaboration with … | ||
| Baxter | Cefazolin in Dextrose Injection | Drugs | Particulate matter (cardboard) found in the solution. | Baxter International Inc. | … discontinue use of and return all affected units in accordance with their facility’s process. Baxter is … regarding this communication, please contact Baxter Healthcare Center for Service at 888-229-0001 between the … | ||
| Long Grove Pharmaceuticals | Cyclophosphamide for Injection | Drugs | Presence of particulate matter identified as steel | Sunny Pharmtech, Inc. | … Cardinal Health to notify pharmacies, hospitals, and other healthcare providers and to coordinate the return, … and destruction of the three lots of recalled product in accordance with the recall strategy. Pharmacies, hospitals, and other healthcare providers that have the recalled product should … | ||
| BD | ChloraPrep Clear – 1 mL Applicators and ChloraPrep FREPP Clear 1.5 mL Applicators | Drugs | Potential fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides | BD | … discontinue use of and destroy all affected units in accordance with their facility’s process. BD will issue … The company supports those on the frontlines of healthcare by developing transformative technologies, … of products annually that have a positive impact on global healthcare. By working in close collaboration with … | ||
| DermaRite | Hand Sanitizers, Cleansers, Skin Protectants, Deodorant | Drugs | Device & Drug Safety - Potential Burkholderia cepacian contamination | DermaRite Industries | … associated with these conditions. DermaKleen is an OTC healthcare antiseptic lotion soap with Vitamin E indicated … available inventory and destroy all affected products in accordance with each facility’s process. Consumers with … . Consumers should contact their physician or healthcare provider if they have experienced any problems … | ||
| Unichem Pharmaceuticals | Cyclobenzaprine Hydrochloride Tablets USP 10 mg | Drugs | Device & Drug Safety – Mislabel | Unichem Pharmaceuticals | … distribute, this medication, and notify their customers accordingly. Retail pharmacies should not dispense from this … – 5 pm; CST). Consumers should contact their physician or healthcare provider if they have experienced any problems … | ||
| DermaKleen, Dermasarra, Kleenfoam, and Perigiene | OTC antiseptic lotion soaps, external analgesics, antimicrobial foam soaps, and antiseptic cleansers | Drugs | Contamination with Burkholderia cepacia | DermaRite Industries, LL | … adverse events related to this recall. DermaKleen is an OTC Healthcare antiseptic lotion soap with Vitamin E indicated … available inventory and destroy all affected products in accordance with each facility’s process. Consumers with … . Consumers should contact their physician or healthcare provider if they have experienced any problems … | ||
| Philips Respironics | Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilators | Medical Devices | The use of in-line nebulizers placed in certain locations may lead to aerosol deposits forming over time on the ventilator flow sensor. Should this occur, there is a possibility of inaccurate flow measurements affecting therapy. | Philips Respironics, Inc. | … and should not discontinue therapy without consulting their healthcare provider. This update, and the associated Urgent … not affected by this issue and can continue to be used in accordance with the guidance in the field safety notice. … by continuous pulse oximetry (SpO2) monitoring in accordance with treatment protocols. Use an external FiO2 … | ||
| ANSWERS | Beef and Chicken Dog Foods | Animal & Veterinary, Foodborne Illness, Pet Food, Food & Beverages, Foodborne Illness, Pet Food | Due to Potential Salmonella and Listeria | Lystn, LLC. d.b.a. ANSWERS | … a product lot identified below, should contact their healthcare provider. Individuals handling pet food can … having contact with such a product should contact their healthcare providers. Children, the elderly, and individuals … quantity, and type, as an adulterant in pet food. In accordance with the Food, Drug and Cosmetic Act, to date, … |