Ropivacaine Hydrochloride Injection — Class I drug recall D-0402-2025
Ongoing recall by Amneal Pharmaceuticals, LLC, reported 2025-05-14, distributed nationwide. Presence of Particulate Matter
| Recall number | D-0402-2025 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amneal Pharmaceuticals, LLC, Bridgewater, NJ, United States |
| Recall initiated | 2025-04-17 |
| Classified | 2025-05-05 |
| Reported by FDA | 2025-05-14 |
| Distributed | Nationwide (US) |
| Quantity | 62 |
| Reason classes | specification failure |
| NDC | 70121-1732, 70121-1732-03, 70121-1732-09, 70121-1733, 70121-1733-03, 70121-1733-09, 70121-1734, 70121-1734-01, 70121-1734-03, 70121-1734-07, 70121-1735, 70121-1735-03, 70121-1735-07 |
| Lot numbers | AL240003, AL240004 |
| Expiration dates | 2026-01-31 |
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)
Reason for recall
Presence of Particulate Matter
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0402-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.