Drug FDA Class I Ongoing Foreign material
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)
Amneal Pharmaceuticals, LLC Published May 14, 2025
Risk level
Class IDangerous or defective — could cause serious health problems or death.
Severity score 85/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Amneal Pharmaceuticals, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Presence of Particulate Matter
Hazards
Particulate Matter · primary
Affected products (1)
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)
ROPIVACAINE HYDROCHLORIDE · 62 (12x100mL) bags
NDC: 70121-1732, 70121-1733, 70121-1734, 70121-1735, 70121-1732-9, 70121-1732-3, 70121-1733-9, 70121-1733-3, 70121-1734-7, 70121-1734-3, 70121-1735-7, 70121-1735-3, 70121-1734-1
Code info: Lot #'s: AL240003, AL240004, Exp.: 01/31/2026
Affected areas
Nationwide
Timeline
- InitiatedApr 17, 2025
- PublishedMay 14, 2025
- Recall number
- D-0402-2025
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.