# Major Recall Alert: Ropivacaine Hydrochloride Injection, USP, 500mg/100mL IV Bag Recalled Due to Polypropylene Fiber Contamination
On April 18, 2025, **Amneal Pharmaceuticals LLC** announced an urgent nationwide recall of its **Ropivacaine Hydrochloride Injection, USP, 500mg/100mL IV Bag**. The decision to recall was made after inert fibers identified as **polypropylene fibers from the IV bag** were found in the product. Such contamination poses serious potential health risks, particularly when the product is used for epidural or intrathecal administration.
Keep reading to learn the details of this critical recall, its implications for patient safety, and what steps healthcare providers and patients should take.
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## Why This Recall is Important
The recall of Ropivacaine Hydrochloride Injection is deeply concerning due to the potential risks posed by **polypropylene particulate contamination**. According to **Amneal Pharmaceuticals LLC**, these synthetic fibers may introduce severe complications, especially when administered into the epidural or intrathecal spaces.
### Possible Risks Include:
- **Epidural inflammatory processes**, which could lead to serious complications such as meningitis.
- **Spinal cord damage**, with possible long-term health consequences.
- When administered intrathecally, contamination could cause:
- **Hydrocephalus (water on the brain)**
- **Embolization**, potentially leading to **organ damage**
No adverse incidents or injuries have been reported yet, but these potential outcomes highlight the gravity of the recall. Medical facilities and healthcare providers must act swiftly to remove the affected products from circulation.
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## Details of the Recall
### Key Information About the Affected Product:
- **Manufacturer**: Amneal Pharmaceuticals LLC
- **Product Name**: Ropivacaine Hydrochloride Injection, USP, 500mg/100mL Infusion Bag
- **Packaging**: 12x100mL Single Dose IV Bags
- **NDC Codes**: 70121-17343
- **Affected Lot Numbers**:
- Lot AL240003 (EXP: 01/2026)
- Lot AL240004 (EXP: 01/2026)
- **Distribution Dates**: April 23, 2024 – November 8, 2024
The product is used for **local or regional anesthesia during surgeries** or **acute pain management**. It was distributed across the U.S. to wholesalers and distributors.
This recall is being conducted in coordination with the U.S. **Food and Drug Administration (FDA)**.
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## What You Should Do
If you are a healthcare provider, distributor, or hospital using this product, it is crucial to take the following steps immediately:
### For Healthcare Providers & Hospitals:
1. **Cease Use Immediately**: Stop using the affected lots of Ropivacaine Hydrochloride Injection.
2. **Check Your Inventory**: Locate and segregate affected products in your inventory.
3. **Contact Amneal Pharmaceuticals** for return instructions:
- **Phone**: 833-582-0812 (Monday–Friday, 8:00 AM–5:00 PM, EST)
- **Fax**: 631-983-2595
- **Email**: [RopivacaineHCl-Recall@amneal.com](mailto:RopivacaineHCl-Recall@amneal.com)
### For Patients:
- If you’ve recently undergone a procedure involving **Ropivacaine Hydrochloride Injection**, consult your healthcare provider immediately to discuss your treatment and potential risks.
### Reporting Adverse Events:
Any adverse reactions or quality issues experienced with this product should be reported to the **FDA MedWatch Adverse Event Reporting Program**:
- **Online**: [MedWatch Online](https://www.accessdata.fda.gov/scripts/medwatch/index.cfm)
- **Regular Mail/Fax**: Download the reporting form [here](https://www.fda.gov/safety/medwatch/how-and-where-report-problems).
For medical inquiries, you can also contact **Amneal Drug Safety** at 1-877-835-5472 or via email ([DrugSafety@amneal.com](mailto:DrugSafety@amneal.com)).
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## Stay Safe – Get Instant Recall Alerts
With product recalls on the rise, it’s vital to stay informed and protect yourself and your loved ones. **Download the MyRecalls app today** for real-time updates on product recalls, safety alerts, and more. Be the first to know, act fast, and stay safe!
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For official recall details, visit the **FDA’s recall announcement** [here](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceutical-llc-issues-nationwide-recall-ropivacaine-hydrochloride-injection-usp).
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Stay informed. Stay safe.