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 |
|---|---|---|---|---|---|---|---|
| Long Grove Pharmaceuticals | Cyclophosphamide for Injection | Drugs | Presence of particulate matter identified as steel | Sunny Pharmtech, Inc. | … Long Grove Pharmaceuticals … Sunny Pharmtech, Inc. … July 24, 2026 - Taoyuan City, Taiwan - Sunny … 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, … | ||
| Baxter | Cefazolin in Dextrose Injection | Drugs | Particulate matter (cardboard) found in the solution. | Baxter International Inc. | … Baxter … Baxter International Inc. … July 24, 2026 – DEERFIELD, Ill., Baxter International … 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 … | ||
| 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, … with customers, BD can help enhance outcomes, lower costs, increase clinical efficiency, improve safety and expand … | ||
| DermaRite | Hand Sanitizers, Cleansers, Skin Protectants, Deodorant | Drugs | Device & Drug Safety - Potential Burkholderia cepacian contamination | DermaRite Industries | … abundance of caution the voluntary recall has expanded to include additional products and lots, which can be found in … 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 … | ||
| Unichem Pharmaceuticals | Cyclobenzaprine Hydrochloride Tablets USP 10 mg | Drugs | Device & Drug Safety – Mislabel | Unichem Pharmaceuticals | … East Brunswick, NJ, Unichem Pharmaceuticals (USA), Inc. is voluntarily recalling one (1) lot of Cyclobenzaprine … 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 … | ||
| 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. | … Philips Respironics … Philips Respironics, Inc. … Additional Usage Instructions issued by Philips as … 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. … | ||
| 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 | … exposed to Listeria monocytogenes . Symptoms in humans may include fever, headache, muscle aches, stiff neck, nausea, … a product lot identified below, should contact their healthcare provider. Individuals handling pet food can … quantity, and type, as an adulterant in pet food. In accordance with the Food, Drug and Cosmetic Act, to date, … | ||
| Tandem | T:Connect Mobile App for iOS Devices | Medical Devices | Rapid Depletion of a User’s t:slim X2 Insulin Pump Battery | Tandem Diabetes Care, Inc. | … Tandem … Tandem Diabetes Care, Inc. … SAN DIEGO – August 12, 2024 – Tandem Diabetes Care, … new possibilities for patients, their loved ones, and healthcare providers. The Company’s pump portfolio features … to use the insulin pump and all other system components in accordance with their respective instructions for use; test … | ||
| Major Pharmaceuticals | Dronabinol Capsules 2.5mg and Ziprasidone Hydrochloride Capsules 20mg | Drugs | Packaging may contain incorrect product due to labeling mix-up | The Harvard Drug Group, LLC d/b/a Major Pharmaceutical and Rugby Laboratories | Terminated | … Dronabinol Capsules, USP, 2.5 mg for Lot T04769. Accordingly, The Harvard Drug Group, LLC is recalling all of … in impairment of mental and/or physical abilities. This can include worsening of symptoms in patients with mental … it to the place of purchase, and contact their physician or healthcare provider. Consumers with questions regarding this … | |
| Midwest Cleaning Solutions, Clean Pro Supply, SOFT HANDS | Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution; Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution | Drugs | Due to Presence of Methanol | Jarman’s Midwest Cleaning Systems, Inc. | Terminated | … Pro Supply, SOFT HANDS … Jarman’s Midwest Cleaning Systems, Inc. … [alerts type="info"] The company has issued a … Solution should stop using and either dispose of it in accordance with local ordinances, or contact Jarman’s … am to 5 pm Central Time. Consumers should contact their healthcare provider if they have experienced any health … |