FDA Recall D-0402-2025

Amneal Pharmaceuticals, LLC · Bridgewater, NJ

Class I — life-threatening Ongoing 392 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

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)

Lot / code: Lot #'s: AL240003, AL240004, Exp.: 01/31/2026

Quantity: 62 (12x100mL) bags

Reason for recall

Presence of Particulate Matter

Recall record

Recall number: D-0402-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the US
Recall initiated: 2025-04-17
Classified by FDA Center: 2025-05-05
FDA published: 2025-05-14
Recalling firm: Amneal Pharmaceuticals, LLC
Firm location: Bridgewater, NJ

Drug identification

Brand name(s): ROPIVACAINE HYDROCHLORIDE
Generic name(s): ROPIVACAINE HYDROCHLORIDE
Manufacturer(s): Amneal Pharmaceuticals LLC
NDC(s): 70121-1732, 70121-1733, 70121-1734, 70121-1735
Route(s): EPIDURAL, INFILTRATION, PERINEURAL

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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