Medications & Supplements/Prescription Drugs

Amneal Ropivacaine Hydrochloride Injection Recalled for Particulate Matter

Agency Publication Date: May 5, 2025

Summary

Amneal Pharmaceuticals, LLC is recalling 62 (12x100mL) bags of Ropivacaine Hydrochloride Injection, USP, 0.5% (500 mg per 100 mL). This medication was found to contain particulate matter in the solution, which can lead to serious health complications when injected. Healthcare providers and hospital staff should immediately identify and isolate the recalled product to prevent patient administration.

Risk

Injecting a product containing particulate matter can cause inflammation, infection, or the blockage of blood vessels. This may result in damage to vital organs or life-threatening blood clots.

What You Should Do

This recall affects Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL) distributed in 100 mL bags under NDC codes 70121-1734-1 (bag) or 70121-1734-3 (box).
Identify if your supply is affected by checking the packaging for lot numbers AL240003 or AL240004 with an expiration date of 01/31/2026.
Stop using the recalled product immediately and secure any remaining inventory to prevent further use.
Contact Amneal Pharmaceuticals or your medical distributor to arrange for the return of the affected product.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL)

Variants: 0.5%, 500 mg per 100 mL, 5 mg/mL, 100 mL bag

UPC Codes:

370121173410

Lot Numbers:

AL240003 (Exp 01/31/2026)

AL240004 (Exp 01/31/2026)

NDC:

70121-1734-1

70121-1734-3

Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807

Product Images

Back of bag, Ropivacaine Hydrochloride Injection, USP, 500mg/100mL

Front of bag, Ropivacaine Hydrochloride Injection, USP, 500mg/100mL

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96648

Status: Active

Manufacturer: Amneal Pharmaceuticals, LLC

Sold By: Hospitals; Surgical Centers; Medical Wholesalers; Healthcare Distributors

Manufactured In: India

Units Affected: 62 (12x100mL) bags

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL) distributed in 100 mL bags under NDC codes 70121-1734-1 (bag) or 70121-1734-3 (box).

Identify if your supply is affected by checking the packaging for lot numbers AL240003 or AL240004 with an expiration date of 01/31/2026.

Stop using the recalled product immediately and secure any remaining inventory to prevent further use.

Contact Amneal Pharmaceuticals or your medical distributor to arrange for the return of the affected product.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

Affected Products

Product: Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL)

Variants: 0.5%, 500 mg per 100 mL, 5 mg/mL, 100 mL bag

UPC Codes:

370121173410

Lot Numbers:

AL240003 (Exp 01/31/2026)

AL240004 (Exp 01/31/2026)

NDC:

70121-1734-1

70121-1734-3

Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807