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 |
|---|---|---|---|---|---|---|---|
| Amneal | Magnesium Sulfate in Water for Injection, USP, 4g/100mL, IV bag | Drugs | A Magnesium Sulfate in Water for Injection pouch was found to contain an IV bag of Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL. | Amneal Pharmaceuticals LLC | … was found to contain an IV bag of Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL. Risk Statement: There is a … between 12/22/2025 and 2/27/2026. Tranexamic acid in 0.7% sodium chloride injection is indicated in patients with … | ||
| B. Braun | Lactated Ringer’s Injection USP 1000 mL/0.9% Sodium Chloride Injection USP 1000 mL | Drugs | Due to the presence of particulate matter. | B. Braun Medical, Inc. | … two lots of Lactated Ringers Injection USP 1000 mL,and 0.9% Sodium Chloride Injection USP 1000 mL to the hospital level due to … or other adverse events associated with this issue. 0.9% Sodium Chloride Injection USP is indicated for extracellular … | ||
| Dr. Reddy’s | Levetiracetam in Sodium Chloride Injection | Drugs | Mislabeling of infusion bag | Dr. Reddy’s Laboratories Ltd. | … one Batch/Lot No: A1540076 of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) single-dose … bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag, … | ||
| 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 | … recalling three lots of Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags (NDC: 71285-6092-1) to … Distributed 71285-6092-1 Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag 37-928390 … | ||
| B Braun | 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers | Drugs | Potential for particulate matter and fluid leakage of the containers | B. Braun Medical Inc. | … (B. Braun), is voluntarily recalling two (2) lots of 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers within … as a source of electrolytes and water for hydration. 0.9% Sodium Chloride for Injection USP in E3 is indicated for … | ||
| Baxter | Heparin Sodium in 0.9% Sodium Chloride Injection | Drugs | Elevated endotoxin levels | Baxter International Inc | … Inc. (NYSE:BAX) is voluntarily recalling one lot of Heparin Sodium in 0.9% Sodium Chloride Injection to the consumer level due to the … | ||
| Hikma | Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) 100 mL | Drugs | Potential presence of Dexmedetomidine HCL Injection (400mcg/100mL) inside the overwrap that is labelled Acetaminophen Injection, 1000mg/100mL, (10mg/mL). | Hikma Pharmaceuticals PLC | … mg acetaminophen, USP, 193 mg anhydrous citric acid, USP, sodium chloride, USP (tonicity agent) and water for injection. pH may be adjusted with hydrochloric acid and/or sodium hydroxide. Acetaminophen Injection is indicated for … | ||
| Grostrong, MoorMan's, MaxLean, Roughage Buster, Pen Pals, Patriot, Goat Power, Juniorglo, Rack Plus, Seniorglo | Animal Feed Products | Animal & Veterinary | Specific lots may contain elevated levels of magnesium, sodium, calcium and/or phosphorus | ADM Animal Nutrition | … DC 505884QN 50-lb. bags 11153AE Lamb Elevated levels of sodium Reduced consumption and increased thirst February 1, … Goats, Lamb, Cattle Elevated levels of calcium and/or sodium Reduced consumption and increased thirst January 17, … Elevated levels of calcium, phospho rus, sodium and/or chloride Toxic levels can lead to reduced feed intake, … | ||
| Medline and Centurion | Convenience kits | Medical Devices | The potential for a lack of sterility | Medline Industries, LP | … branded convenience kits containing Nurse Assist 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation … | ||
| Fendall 2000 | Non-Sterile Eyewash Cartridge | Drugs | Non-compliance with current good manufacturing practice (cGMP) requirements. | Honeywell Safety Products USA | … eyewash solution contains purified water, benzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate diabasic, and sodium … |