Ropivacaine Hydrochloride Injection
FDA Recall NDC 70121-1734
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Ropivacaine Hydrochloride (NDC 70121-1734). A significant event, classified as Class I, was initiated on Apr 17, 2025 by Amneal Pharmaceuticals Llc. The reported reason for this action was: "Presence of Particulate Matter"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class I Ongoing
Presence of Particulate Matter
Apr 17, 2025
May 14, 2025
62 (12x100mL) bags
Recall Profile & Regulatory Data
Event ID
96648
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Amneal Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Product Description
Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, India, , Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 NDC 70121-1734-1 (bag); NDC 70121-1734-3 (box)
Batch or Lot Expiration Information
Lot# 's: AL240003, AL240004, Exp.: 01/31/2026
Affected Packages Involved in this Recall
70121-1732-9Product
70121-1732-3Product
70121-1733-9Product
70121-1733-3Product
70121-1734-7Product
70121-1734-3Product
70121-1735-7Product
70121-1735-3Product
70121-1734-1Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
