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 |
|---|---|---|---|---|---|---|---|
| Fresenius Kabi | Tyenne Injection 400 mg/20 mL vial | Drugs | Due to Presence of Glass Particles | Fresenius Kabi | … at the firm found the product to contain glass particles. Risk Statement: The administration of an … and is arranging for return of the recalled product. If health care facilities have any of the affected lot, they … questions regarding this recall can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through … | ||
| Fresenius Kabi | Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL | Drugs | Due to a label mix-up | Fresenius Kabi | … mL has a reasonable probability of causing serious adverse health consequences, including life-threatening respiratory … questions regarding this recall can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through … reported to Fresenius Kabi Medical Affairs or Vigilance departments at 1-800-551-7176, Monday through Friday, during … | ||
| Oribe | Oribe Serene Scalp Densifying Shampoo (8.5 oz and 33.8 oz) | Cosmetics | May be contaminated with Pluralibacter gergoviae bacteria | KAO USA | … Oribe … KAO USA … Select units of Oribe Serene Scalp Densifying Shampoo … gergoviae bacteria pose little medical risk to healthy people, those with certain health issues such as … from our warehouses. We are also asking retail and salon partners to remove affected lots from use and/or sale and … | ||
| Nara Organics | Whole Milk Powdered Infant Formula | Food & Beverages | Potential risk of Clostridium botulinum contamination. | Nara Organics | … fatal illness that presents a serious threat to the health of infants which occurs when Clostridium botulinum … 2026. Nara Infant Formula is not distributed outside of the USA. Affected Product Details: Nara Organics Whole Milk … Centers for Disease Control and Prevention (CDC), and state partners to support their investigation into the root causes … | ||
| a2 | a2 Platinum Premium Infant Formula 0-12 months USA label | Food & Beverages, Infant Formula & Foods | Presence of cereulide toxin produced by some strains of the bacterium Bacillus cereus | A2 Milk Company | Terminated | … three specific batches of its imported a2 Platinum Premium USA label infant formula 0-12 months (“Product”) due to the … the consumption of food contaminated with the toxin and preparing formula with hot water does not eliminate it. … is experiencing symptoms described above, contact your health care provider immediately. To report an illness or … | |
| Great Value | Cottage Cheese | Food & Beverages, Cheese/Cheese Product | Not fully pasteurized. | Saputo Cheese USA, Inc. | … Great Value … Saputo Cheese USA, Inc. … [alerts type="info"]“The company has issued a … that are not fully pasteurized can pose a significant health risk, especially to the young and elderly or … conducted by SUSA in conjunction with the California Department of Food and Agriculture. The impacted pasteurizer … | ||
| Why Not Natural | Organic Moringa – Green Superfood | Food & Beverages, Foodborne Illness | Potential Foodborne Illness - Salmonella | Why Not Natural | … or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience … mail orders on Why Not Natural’s e-commerce site and third-party on-line retailers including Amazon.com from July 2025 … Why Not Natural Moringa Capsules are urged to stop usage and may return them to the company. Consumers may … | ||
| Fresenius Kabi | Famotidine Injection, USP 20 mg per 2 mL | Drugs | Out-of-specification endotoxin results | Fresenius Kabi USA, LLC | … Fresenius Kabi … Fresenius Kabi USA, LLC … [alerts type="info"] “Press has been corrected to … [/alerts] Nov. 6,2025 – LAKE ZURICH, Ill.— Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of … | ||
| Unichem Pharmaceuticals | Cyclobenzaprine Hydrochloride Tablets USP 10 mg | Drugs | Device & Drug Safety – Mislabel | Unichem Pharmaceuticals | … – 08/27/2025– East Brunswick, NJ, Unichem Pharmaceuticals (USA), Inc. is voluntarily recalling one (1) lot of … gastrointestinal, renal, anaphylaxis, and skin reactions, particularly in those patients taking concomitant … – 5 pm; CST). Consumers should contact their physician or healthcare provider if they have experienced any problems … | ||
| Brie Royal Faucon | Brie Royal Faucon Cheese | Food & Beverages | Potential contamination with Listeria monocytogenes | Fromi USA | Terminated | … Brie Royal Faucon … Fromi USA … FROMI USA of New York, NY is recalling 12 Cases of … people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such … The Brie Royal Faucon 1kg was distributed to Cheese Plate Park Slope LLC, located at 400 7th Avenue, 11215 Brooklyn … |