FDA Drug recall D-0402-2025
Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt
- FDA Drug
- Class I
- ongoing
- Published 2025-05-14
On 2025-05-14 the FDA classified a Class I recall of Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt by Amneal Pharmaceuticals, citing presence of Particulate Matter.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0402-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-04-17 |
| Published | 2025-05-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amneal Pharmaceuticals |
| Distribution | US |
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
Presence of Particulate Matter
Identifiers
| ndc | 70121-1732-9 |
|---|---|
| ndc | 70121-1732-3 |
| ndc | 70121-1733-9 |
| ndc | 70121-1733-3 |
| ndc | 70121-1734-7 |
| ndc | 70121-1734-3 |
| ndc | 70121-1735-7 |
| ndc | 70121-1735-3 |
| ndc | 70121-1734-1 |
| code_info | Lot #'s: AL240003, AL240004, Exp.: 01/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Amneal Pharmaceuticals
- Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-…
FDA Drug · Class II · 2026-10-07 · Amneal Pharmaceuticals - Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured b…
FDA Drug · Class II · 2026-09-30 · Amneal Pharmaceuticals - Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt
FDA Drug · Class III · 2026-06-17 · Amneal Pharmaceuticals - traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt
FDA Drug · Class II · 2026-04-08 · Amneal Pharmaceuticals - Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufact…
FDA Drug · Class I · 2026-04-08 · Amneal Pharmaceuticals
All Amneal Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0402-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.