Ropivacaine recalls
The FDA has published 5 recalls involving Ropivacaine since 2018. The latest was reported on 29 Jul 2026. Most were for particulate matter. Akorn has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls5since 2018
Last 12 months1reported
Class I120% of total
Ongoing4latest 29 Jul 2026
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 1 20%Class II 4 80%Class III 0 0%
Why ropivacaine is recalled
Companies
Brands
By year
Ongoing ropivacaine recalls
4 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Naropin (ropivacaine hydrochloride Injection, USP) recalledNaropin | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS I | Ropivacaine Hydrochloride Injection, USP, 5%, 500 mg per (5mg/mL) recalledRopivacaine Hydrochloride | Amneal Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Ropivacaine Hydrochloride Injection USP, 5%, 150mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Ropivacaine Hydrochloride Injection USP, 2%, 200mg/ (2 mg/mL) Vial recalled | Akorn | Potency & Assay | Nationwide |
All ropivacaine recalls, newest first
5 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Naropin (ropivacaine hydrochloride Injection, USP) recalledNaropin | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS I | Ropivacaine Hydrochloride Injection, USP, 5%, 500 mg per (5mg/mL) recalledRopivacaine Hydrochloride | Amneal Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Ropivacaine Hydrochloride Injection USP, 5%, 150mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Ropivacaine Hydrochloride Injection USP, 2%, 200mg/ (2 mg/mL) Vial recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Ropivacaine HCl Injection in all strengths, all doses recalled | Pharmedium Services | Sterility | Nationwide |
Should you stop taking Ropivacaine?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.