CLASS I Drug recall · Reported 14 May 2025 · FDA Enforcement Report
Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per (5mg/mL) recalled
Amneal Pharmaceuticals is recalling Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per (5mg/mL), distributed nationwide in the US. The recall was initiated on 17 Apr 2025 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0402-2025
- FDA event ID
- 96648
- Recalling firm
- Amneal Pharmaceuticals, Bridgewater, NJ
- Manufacturer
- Amneal Pharmaceuticals LLC
- Classification
- Class I
- Status
- Completed
- Recall initiated
- 17 Apr 2025
- FDA classified
- 5 May 2025
- Reported
- 14 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Apr 2025 | Recall initiated by company | |
| 5 May 2025 | Classified by FDA | +18 days |
| 14 May 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter
Product as listed by the FDA
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)
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
Presence of Particulate Matter
Which lots are affected?
Lot #'s: AL240003, AL240004, Exp.: 01/31/2026
Where was it sold?
Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 9 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Ropivacaine recalls
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Naropin (ropivacaine hydrochloride Injection, USP) recalledNaropin | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/ (2 mg/mL) Vial recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Ropivacaine HCl 2 mg/mL recalled by Guardian Pharmacy Services | Guardian Pharmacy Services | Sterility | TX |