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 |
|---|---|---|---|---|---|---|---|
| TRUE METRIX | Blood Glucose Monitoring Systems | Medical Devices | As currently written, the Owner’s Booklets/System Instructions for Use fails to emphasize that users must seek medical attention immediately if they receive an E-5 error code and are experiencing symptoms of high glucose. | Trividia Health, Inc. | … factors, please discuss with your healthcare provider or pharmacist. Updated TRUE METRIX Meters and Future Upgrade … wellness company based in Fort Lauderdale, Florida and a leading developer, manufacturer and marketer of advanced … and health and wellness solutions for the world’s leading retail pharmacies, distributors and mail service … | ||
| TRUE METRIX | Blood Glucose Monitoring Systems | Medical Devices | As currently written, the Owner’s Booklets/System Instructions for Use fails to emphasize that users must seek medical attention immediately if they receive an E-5 error code and are experiencing symptoms of high glucose. | Trividia Health, Inc. | … to device users, if possible. These customers include pharmacies, mail order companies, and distributors where the … wellness company based in Fort Lauderdale, Florida and a leading developer, manufacturer and marketer of advanced … and health and wellness solutions for the world’s leading retail pharmacies, distributors and mail service … | ||
| TRUE METRIX | Blood Glucose Meters | Medical Devices | Potential for defective LCD displays that can affect product performance | Trividia Health, Inc. | … Blood glucose meters co-branded under the Good Neighbor Pharmacy® brand and distributed in the United States. The … wellness company based in Fort Lauderdale, Florida and a leading developer, manufacturer and marketer of advanced … and health and wellness solutions for the world’s leading retail pharmacies, distributors and mail service … | ||
| CAPS | Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag | Drugs | Due to visible black particulate matter | CAPS | … – February 24, 2025 – Bethlehem, PA. Central Admixture Pharmacy is recalling three lots of Phenylephrine 40 mg … blocking blood vessels in the heart, lungs or brain, leading to serious complications such as stroke or even … mail and is arranging for return. By completing a “Urgent Pharmaceutical Recall Response Form” and either faxing the … | ||
| Provepharm Inc. | Phenylephrine hydrochloride Injection, USP, 10 mg/ mL | Drugs | Device & Drug Safety – Potential Foreign Material | Provepharm Inc. | … of Phenylephrine hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) at the hospital/institutional level. … recall was initiated based on a customer complaint from a pharmacy after observing a visible black particulate matter … blocking blood vessels in the heart, lungs or brain, leading to serious complications such as stroke or even … | ||
| Dr. Reddy’s | Sapropterin Dihydrochloride Powder for Oral Solution 100 mg | Drugs | Decreased Potency | Dr. Reddy’s Laboratories Inc | … consumer level due to powder discoloration in some packets leading to decreased potency. The issue was discovered … NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. … | ||
| Amneal | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL | Drugs | Super potent due to bottles being overfilled | Amneal Pharmaceuticals, LLC. | Terminated | … Amneal … Amneal Pharmaceuticals, LLC. … FOR IMMEDIATE RELEASE – March 27, 2024 - Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey (Amneal), is … with electrolyte abnormalities such as high potassium leading to cardiac arrest. To date, Amneal has not received … | |
| Merck Animal Health | Banamine; Banamine-S | Animal & Veterinary, Animal Drugs | Potential presence of particulate matter | Merck Animal Health | … we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the … and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions … of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care … | ||
| BIOCELL® | BIOCELL® textured breast implants and tissue expanders | Medical Devices, General & Plastic Surgery | Due to uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) | Allergan plc | … (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative … patients around the world. Allergan markets a portfolio of leading brands and best-in-class products primarily focused … |