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 |
|---|---|---|---|---|---|---|---|
| ICU Medical LLC | 0.9% Sodium Chloride Injection, USP, 100 mL | Drugs | Product mix-up where 0.9% Sodium Chloride Injection, USP overwrap may contain 10 mEq Potassium Chloride Injection | Otsuka ICU Medical LLC | … LLC is issuing a voluntary recall for one lot of 0.9% SODIUM CHLORIDE Injection, USP, 100mL single pack to the user level due to a potential mix-up. The affected lot of 0.9% SODIUM CHLORIDE Injection, USP (NDC: 0990-7984-23 Lot … | ||
| Par Pharmaceutical | Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) for Intravenous Infusion | Drugs | Presence of particulate matter identified as cellulose or stopper material | Par Health | … recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) to the hospital … material. Administration of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL, found to contain … | ||
| B. Braun | 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container | Drugs | Presence of particulate matter identified as iron oxide | B. Braun Medical Inc. | … (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, … particulate matter. Risk Statement: Administration of 0.9% Sodium Chloride Injection USP, found to contain particulate … | ||
| Baxter | 0.9% Sodium Chloride Injection, USP, 500 mL VIAFLEX Plastic Container | Drugs | Potential presence of particulate matter identified as fiberglass in the solution. | Baxter International Inc. | … Inc. (NYSE:BAX) is voluntarily recalling two lots of 0.9% Sodium Chloride Injection due to the potential presence of … Risk Statement: Intravenous administration of 0.9% Sodium Chloride Injection containing fiberglass particulate … | ||
| 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 … | ||
| 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 … |