FDA Drugs recall ·
Ropivacaine Hydrochloride Injection, USP, 0.5%… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0402-2025
- Date
- (initiated April 17, 2025)
- Company / brand
- Amneal Pharmaceuticals, LLC
400 Crossing Blvd Fl 3, Bridgewater, NJ, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Completed
- Units affected
- 62 (12x100mL) bags
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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)
Why was it recalled?
Presence of Particulate Matter
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #'s: AL240003, AL240004, Exp.: 01/31/2026
Distribution
Nationwide in the US
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0402-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.