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.
Sign up to receive Recalls, Market Withdrawals and Safety Alerts.* FDA Employees: Use Chrome to Subscribe until further notice.
| Date | Brand Name(s) | Product Description | Product Type | Recall Reason Description | Company Name | Terminated Recall | Excerpt |
|---|---|---|---|---|---|---|---|
| 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, … | ||
| 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. | … 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 blood glucose levels as recommended by their healthcare provider; demonstrate adequate carb-counting … | ||
| 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 … it to the place of purchase, and contact their physician or healthcare provider. Consumers with questions regarding this … . Consumers should contact their physician or healthcare provider if they have experienced any problems … | |
| 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 | … 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 … | |
| Banana Boat | Hair & Scalp Spray SPF 30 | Drugs | Due to presence of benzene | Edgewell Personal Care | Terminated | … would not be expected to cause adverse health consequences according to an independent health assessment using … products. Consumers should contact their physician or healthcare provider if they have any questions, concerns or … |