Recalls / Class I
Class ID-0402-2025
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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)
- Brand name
- Ropivacaine Hydrochloride
- Generic name
- Ropivacaine Hydrochloride
- Active ingredient
- Ropivacaine Hydrochloride
- Route
- Epidural, Infiltration, Perineural
- NDCs
- 70121-1732, 70121-1733, 70121-1734, 70121-1735
- FDA application
- ANDA216605
- Affected lot / code info
- Lot #'s: AL240003, AL240004, Exp.: 01/31/2026
Why it was recalled
Presence of Particulate Matter
Recalling firm
- Firm
- Amneal Pharmaceuticals, LLC
- Manufacturer
- Amneal Pharmaceuticals LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Crossing Blvd Fl 3, N/A, Bridgewater, New Jersey 08807-2863
Distribution
- Quantity
- 62 (12x100mL) bags
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2025-04-17
- FDA classified
- 2025-05-05
- Posted by FDA
- 2025-05-14
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0402-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.