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 |
|---|---|---|---|---|---|---|---|
| Hospira | Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection, USP Carpuject Units | Animal & Veterinary, Animal Drugs, Drugs, Animal Drugs | Device & Drug Safety – Potential Packaging Defect | Hospira Inc. | … RELEASE – May 21, 2024 - NEW YORK, NY., Hospira, Inc., a Pfizer company (“Pfizer”), is voluntarily recalling the lots listed in the … in the need for additional medical treatment. To date, Pfizer has not received reports of any relevant adverse … | ||
| Hospira | 4.2% Sodium Bicarbonate Injection, USP, 1% Lidocaine HCl Injection, USP, and 2% Lidocaine HCl Injection, USP | Drugs | Potential Presence of Glass Particulates | Hospira, Inc. | Terminated | … RELEASE - October 2, 2023 - NEW YORK, NY., Hospira, Inc., a Pfizer company, is voluntarily recalling the lots listed in … injector/ carton 10 cartons/ bundle Case pack 5 X 10- 5mL Pfizer places the utmost emphasis on patient safety and … every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange … | |
| Hospira | Propofol Injection Emulsion, USP | Drugs | Potential presence of visible particulate | Hospira, Inc., a Pfizer Company | Terminated | … Hospira … Hospira, Inc., a Pfizer Company … FOR IMMEDIATE RELEASE -NEW YORK, NY., August 22, 2022 Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Propofol … transmission of infectious disease can also occur. To date, Pfizer has not received reports of any adverse events … | |
| Pfizer | Accupril (Quinapril HCl) tablets 10mg, 20mg, 40 mg | Drugs | Due to N-Nitroso-Quinapril Content | Pfizer | Terminated | … Pfizer … Pfizer … FOR IMMEDIATE RELEASE - NEW YORK, NY., April 22,2022. Pfizer is voluntarily recalling five (5) lots of Accupril (Quinapril HCl) tablets distributed by Pfizer to the patient (consumer/user) level due to the … | |
| CHANTIX | Varenicline tablets | Drugs | N-nitroso-varenicline above acceptable daily intake level | Pfizer | … CHANTIX … Pfizer … Pfizer is voluntarily recalling all lots of Chantix 0.5 mg … suppliers have been approved in the United States, Pfizer is undertaking this precautionary measure. Long-term … | ||
| CHANTIX | Smoking cessation treatment | Drugs | N-Nitroso Varenicline content above ADI level | Pfizer | … CHANTIX … Pfizer … Pfizer is voluntarily recalling two lots of Chantix 0.5mg … presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level. … |