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 | … Amneal … Amneal Pharmaceuticals LLC … FOR IMMEDIATE RELEASE – 03/24/2026 – Bridgewater, New Jersey , Amneal Pharmaceuticals LLC is voluntarily recalling one lot of … | ||
| Amneal | Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg | Drugs | Microbial contamination | Amneal Pharmaceutical LLC | … Amneal … Amneal Pharmaceutical LLC … Amneal Pharmaceutical LLC, is … the concern for serious infections. To date, Amneal Pharmaceuticals has received no reports of adverse events, … with questions regarding this recall can contact Amneal Pharmaceuticals by: Phone: 833-582-0812 Monday-Friday, 8:00 … | ||
| Amneal Pharmaceuticals LLC. | Ropivacaine Hydrochloride Injection, USP, 500mg/100mL IV bag | Drugs | Product may contain an inert fiber identified as polypropylene fibers from the IV bag | Amneal Pharmaceuticals LLC. | … Amneal Pharmaceuticals LLC. … Amneal Pharmaceuticals LLC. … FOR IMMEDIATE RELEASE – 04/18/2025 – … | ||
| 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 … |