Amneal Pharmaceuticals recalls 0.5% Ropivacaine Hydrochloride Injection due to particulate matter risk. Affected lots expire 01/31/2026. Contact for return instructions.
Presence of Particulate Matter
Amneal Pharmaceuticals is recalling certain ropivacaine injections because they may contain particles that could cause serious injury if injected. This recall affects specific lots manufactured in India and distributed in the US.
Particulate matter in the injection could enter the bloodstream during medical procedures, potentially causing blockages, infections, or other serious complications. This risk is particularly concerning for procedures requiring precise medication delivery.
Healthcare professionals using the recalled injection for medical procedures are affected. Patients receiving injections from this product are at risk of serious injury.
Check the NDC numbers: 70121-1734-1 (bag) or 70121-1734-3 (box). The product was manufactured in India with lot numbers AL240003 or AL240004 and expires January 31, 2026.
Immediately stop using the recalled ropivacaine injection if you have it. Do not administer or inject the product.
The recalled product is Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL) with NDC numbers 70121-1734-1 (bag) or 70121-1734-3 (box).
Immediately stop using the product and contact Amneal Pharmaceuticals for return instructions.
The recalled product expires January 31, 2026.
We’ve drafted a message you can send Amneal to request your refund or repair — edit it as you like.
Subject: Recall D-0402-2025 — Amneal Amneal Hello, I own a Amneal that is covered by recall D-0402-2025 from Amneal. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
