← FDA ENFORCEMENT
D-0402-2025Class I

Amneal Pharmaceuticals, LLC

Recalling firm
Amneal Pharmaceuticals, LLC
Product type
Drug
Status
Ongoing
Report date
2025-05-14
Distribution
Nationwide in the US
Firm state
NJ
Product quantity
62 (12x100mL) bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Presence of Particulate Matter

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)

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.